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Funding | This work is supported by National Natural Science Foundation of China (No.31000675), Key R & D projects of Shaanxi Province (2018SF-010), Henan Medical Science and Technology Project (2018020689, LHGJ20190956), and Projects of Xi’an International Medical Center Hospital (2022MS14). | PMC10155412 | ||
Data availability | The datasets used and/or analysed during the current study are available from the | PMC10155412 | ||
Declarations | PMC10155412 | |||
Ethics approval and consent to participate | This study was approved by the medical ethics committee, the second affiliated hospital of Xi’an Jiaotong University (2018024) and written informed consent was approved by each patient’s legal guardian. The study was registered at | PMC10155412 | ||
Consent for publication | Not applicable. | PMC10155412 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10155412 | ||
Abbreviations | Parent-Controlled Intravenous AnalgesiaBody Mass IndexAmerican Society of AnesthesiologistsCase Report Formelectrocardiogrampulse oximetryHeart RateNoninvasive Blood PressureBispectral IndexPost-Anesthesia Care Unitface, legs, activity, cry, consolabilityfunctional activity score | PMC10155412 | ||
References | PMC10155412 | |||
Background | RDS | RESPIRATORY DISTRESS SYNDROME, COMPLICATIONS | The benefit of surfactant replacement therapy for respiratory distress syndrome (RDS) has been demonstrated. However, some surfactants are expensive and usually inaccessible. Consequently, the Iranian Survanta was produced, but its effect on complications and mortality of RDS is unknown. This study aimed to compare the therapeutic outcomes of Iranian surfactant (beraksurf) and BLES (bovine lipid extract surfactant) on RDS treatment among preterm neonates. | PMC10691073 |
Methods | Congenital anomalies, IVH, digestive system anomalies, patent ductus arteriosus, RDS, congenital cyanotic heart diseases, sepsis | PNEUMOTHORAX, INTRAVENTRICULAR HEMORRHAGE, PULMONARY HEMORRHAGE, SEPSIS, COMPLICATIONS, CHROMOSOME ABNORMALITIES | This triple blinded randomized controlled trial study was performed on 128 eligible neonates diagnosed with RDS in Afzalipour hospital in Kerman, Iran. Diagnosis of RDS, gestational age of 28–34 weeks and weight ≥ 1 kg were considered as inclusion criteria. Congenital anomalies such as congenital cyanotic heart diseases, digestive system anomalies and chromosome abnormalities were the exclusion criteria Neonates were randomly assigned into two equal groups: (1) those treated with BLES (n = 64) and (2) those treated with beraksurf (n = 64). Complications including patent ductus arteriosus (PDA), sepsis, intraventricular hemorrhage (IVH), pneumothorax, pulmonary hemorrhage, mortality, and also, the number of days required for invasive mechanical ventilation (using ventilator) and non-invasive continuous positive airway pressure (CPAP) were evaluated for all neonates. The risk ratio (RR) was calculated at 95% of confidence intervals (CI). | PMC10691073 |
Results | sepsis, IVH | SEPSIS, PULMONARY HEMORRHAGE, PNEUMOTHORAX | Compared with BLES group, the RR estimate among neonates in beraksurf group was 0.89 (0.66–1.20) for PDA, 0.71 (0.23–2.13) for IVH, 0.44 (0.14–1.36) for sepsis, 0.35 (0.13–0.93) for pneumothorax, 0.33 (0.12–0.86) for pulmonary hemorrhage, and 0.55 (0.28–1.05) for mortality. | PMC10691073 |
Conclusions | NEONATAL RESPIRATORY DISTRESS SYNDROME, RESPIRATORY DISTRESS SYNDROME | Despite advances in the use of exogenous surfactants for the treatment of neonatal respiratory distress syndrome; There are still some controversial topics in this field. The results obtained in the present study showed that the two types of surfactant (BERAKSURF and BLES) have similar efficacy for the treatment and short-term outcomes in preterm infants with respiratory distress syndrome. Therefore, due to the cost-effectiveness of BRAKSURF compared to BLES, We recommend choosing BERAKSURF in terms of treatment. | PMC10691073 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12887-023-04406-2. | PMC10691073 | ||
Keywords | PMC10691073 | |||
Background | patent ductus arteriosus, RDS | RESPIRATORY DISTRESS SYNDROME | Respiratory distress syndrome (RDS) is a prevalent cause of morbidity and mortality in premature neonates [Normally, surfactant is present in the amniotic fluid from the 28th week of gestation, and its production depends on normal pH, temperature, and perfusion [So far, there are many studies that have evaluated the effect of natural and synthetic surfactants on RDS treatment [A clinical trial in the United States comparing the effect of survanta surfactant and curosurf in premature babies with an average gestational age of 26–29 weeks and an average weight of 1400 g, reported a decrease in supplemental oxygen in babies receiving curosurf as well as the prevalence of patent ductus arteriosus in babies receiving curosurf Compared to surventa, it was reported less with a statistically significant difference [Another clinical trial was conducted in Zika-free NICU of Turkey in infants less than 37 weeks gestational age from July 2008 to June 2009. 126 premature babies with RDS in two groups had similar basic demographic characteristics; In this study, the group receiving survanta surfactant required two or more doses compared to treatment with Corosurf; Also, extubation in the corosurf group was more within the first three days of drug administration, and the need for Fio2 after treatment on the first, third and fifth days was significantly lower in the corosurf group. Although the rate of mortality and morbidity of the two groups were similar, the findings of the study indicated an increase in the chance of survival in the corosurf group [This clinical trial study is designed to compare the effect of the Canadian BLES with the Iranian Survanta as an efficient surfactant. | PMC10691073 |
Methods | PMC10691073 | |||
Study population | Congenital anomalies, digestive system anomalies, RDS, cyanosis, congenital cyanotic heart diseases | CHROMOSOME ABNORMALITIES | This triple-blind randomized clinical trial study was performed on hospitalized neonates in neonatal intensive care unit (NICU) of Afzalipour hospital (Kerman, Iran) between April 1, 2020 and February 1, 2021. Diagnosis of RDS, gestational age of 28–34 weeks and weight ≥ 1 kg were considered as inclusion criteria. Congenital anomalies such as congenital cyanotic heart diseases, digestive system anomalies and chromosome abnormalities were the exclusion criteria.RDS diagnosis and its severity was conducted based on classic clinical presentation of RDS includes grunting respirations, retractions, nasal flaring, cyanosis, and increased oxygen requirement, together with diagnostic finding and onset of symptoms shortly after birth [ | PMC10691073 |
Study design | Sample size was calculated at 95% confidence interval (CI) and 80% power based on a similar study [
Flowchart of patients’ enrollment in the two different groups | PMC10691073 | ||
Randomization and allocation concealment | A random number sequence was generated by a person who was not involved in the study, using computer random sequence Stata software version 12. Allocation concealment was performed using numbered, opaque, and sealed envelopes that were opened by the primary researcher at the randomization time. Therefore, all participants had equal chances of being assigned to any group. | PMC10691073 | ||
Blinding | The neonates, data collectors, assessors, and analysts were unaware of the type of surfactant in each group and were blinded, making this study triple-blind. | PMC10691073 | ||
Intervention | Two types of surfactants were used for intervention in this study. One group received BLES 135 mg/kg (produced by Blesbiochemical, Canada) and the other group received Survanta (Beraksurf®) 100 mg/kg (produced by Tekzima, Iran). Drug administration in both groups was performed intratracheally for 10 min. The first dose was given immediately after hospitalization, and if it was not required at that time, it was prescribed in the hospitalization period and with deterioration of RDS (this deterioration was not justifiable with other causes).Chest radiography was performed in both groups 6 h after the first dose. Based on radiographic findings and neonate clinical condition, second and third dose were either prescribed or unfixed. | PMC10691073 | ||
Outcomes | sepsis, pulmonary hemorrhage, pneumothorax, IVH | PULMONARY HEMORRHAGE, SEPSIS, PNEUMOTHORAX, COMPLICATIONS | The number of days required for the use of invasive mechanical ventilation (ventilator) and non-invasive continuous positive airway pressure (CPAP) was recorded for all neonates. Some complications were evaluated. These complications are PDA (assessed by echocardiography), IVH (assessed by sonography), sepsis (using blood culture), and pneumothorax (using chest X-ray; and assessed by clinical symptoms) and pulmonary hemorrhage (using chest X-ray; and assessed by clinical symptoms). The mortalities in both groups were also recorded. | PMC10691073 |
Statistical analysis | Data analysis was performed with Stata software version 12 (StataCorp, College Station, TX, USA), and | PMC10691073 | ||
Results | IVH | COMPLICATIONS, INTRAVENTRICULAR HEMORRHAGE | The mean of the gestational age of neonates in Beraksurf and BLES surfactant groups were 31.64 ± 1.69 weeks and 31.03 ± 1.96 weeks and the difference was not significant (
Baseline and Demographic Information* P−value was calculated using chi−2 statistic test at 95% level of confidence interval and independent t−testThe mean time to receive surfactant was 4.49 ± 1.18 h in Beraksurf group and 4.24 ± 1.09 in BLES group. Time of receipt of surfactant in Beraksurf group was ≤ 12 h in 35 (54.7%), 2–12 h in 25 (39.1%) and ≥ 12 h in 4 (6.2%) neonates. In BLES group, it was ≤ 12 h in 35 (54.7%), 2–12 h in 27 (42.2%), and ≥ 12 h in 2 (3.1%) neonates. There was no significant difference between the mean post-natal age of surfactant administration in both groups (The mean days of hospital stay were 17.66 ± 1.46 days and 16.68 ± 1.46 days in Beraksurf and BLES groups respectively; however, this difference was not significant (Table
Comparison of effects of the two types of surfactants on complications among neonates* RR: risk ratio, PDA: patent ductus arteriosus, IVH: intraventricular hemorrhage | PMC10691073 |
Discussion | ®, pneumothorax, IVH, pulmonary hemorrhage, RDS, sepsis, diabetes | PNEUMOTHORAX, PULMONARY HEMORRHAGE, SEPSIS, COMPLICATIONS, DIABETES | The prevalence of RDS is 45% [In this study, we compared a new and cost-effective surfactant produced in Iran with a relatively more expensive and inaccessible surfactant. Based on our results, there were no significant differences between frequencies of gender, type of delivery and diabetes in mothers in BLES and Beraksurf groups. In the present study, neonates treated with Beraksurf experienced the complications such as PDA, IVH, sepsis, pneumothorax, and pulmonary hemorrhage less frequently than those treated with BLES. From all these assessed complications, only pneumothorax and pulmonary hemorrhage caused significant statistical difference between the two groups. Also, the mortality rate in Beraksurf group was 17.2% and was lower than BLES group (31.3%), however, the The Beraksurf treatment in our study is a cost-effective and available surfactant; based on our results, its effect on RDS complications is similar to BLES. When compared with BLES, incidence risk of some complications such as pneumothorax and pulmonary hemorrhage in RDS patients is lower with this surfactant. BLES was first used in 1983; this Canadian surfactant is a powerful and effective drug in RDS treatment and is a fully natural human surfactant produced from amniotic fluid or biosynthetic materials. But, the Survanta is a natural corrected surfactant that is produced in some countries. In Iran this surfactant with the brand name Beraksurf® was produced by Tekzima pharmaceutical company. The chemical component of Beraksurf is similar to other Survanta and it is expected to be an effective surfactant with lower price and more availability.Some studies compared the non-Iranian Survanta with other surfactants (given the similarity of Iranian Survanta to Survanta manufactured in other countries). In a study conducted by Macooie et al. [ | PMC10691073 |
Conclusions | RDS | COMPLICATIONS | Considering the effectiveness of neonatal RDS treatment and ventilator-induced complications in these patients, we recommend the use of surfactant replacement therapy. Our scientific study assessed Beraksurf®, an Iranian Survanta, as effective as international surfactant products on neonatal RDS treatment and safe enough to be prescribed. Hence, we suggest the clinicians to consider it as an alternative when international brands are more expensive and inaccessible. | PMC10691073 |
Acknowledgements | This study was supported by the pediatric health research center at the Kerman University of Medical Sciences. We thank the NICU nurses involved in the care of the neonates studied in this report. | PMC10691073 | ||
Authors’ contributions | F.S. designed the initial concept, prepared the manuscript, and helped with the first draft of the manuscript. B.B., Z.D.P. and Z.J. designed the initial concept. M.E. participated in manuscript preparation and data collection. F.K.R. participated in revising manuscript. All authors read and approved of the final version of article. | PMC10691073 | ||
Funding | This study was supported by the pediatric health research center at the Kerman University of Medical Sciences. We thank the NICU nurses involved in the care of the neonates studied in this report. | PMC10691073 | ||
Data Availability | All data generated or analyzed during this study are included in this published article. | PMC10691073 | ||
Declarations | PMC10691073 | |||
Ethics approval and consent to participate | This study was conducted in accordance to the Declaration of Helsinki. The ethics committee of Kerman University of medical sciences approved this study (Code: IR.KMU.AH.REC.1400.012). In addition, this study was approved by the Iranian Registry of Clinical Trials (IRCT) (Code: IRCT20210501051148N1) in 11/07/2021. Written informed consent was obtained from parents. | PMC10691073 | ||
Consent for publication | Not applicable. | PMC10691073 | ||
Competing interests | The authors of this study claim no conflicts of interest. | PMC10691073 | ||
List of abbreviations | respiratory distress | respiratory distress syndromepatent ductus arteriosusintraventricular hemorrhagecontinuous positive airway pressurerisk ratioconfidence intervalsneonatal intensive care unitstandard deviation | PMC10691073 | |
References | PMC10691073 | |||
Abstract | PMC10407975 | |||
Objective | weight gain, immature gastrointestinal tract | Feeding intolerance (FI) is a common condition in preterm infants because they have an immature gastrointestinal tract. There are studies on the effects of the position on gastric residual volume (GRV) in preterm infants. Kangaroo mother care (KMC) may be an instrument for reducing FI by providing an upright position to infants. Moreover, numerous studies conducted with this therapeutic position applied by putting an infant on the mother’s chest have indicated its positive effects on the infant’s weight gain, growth and development, and vital signs. Therefore, this study aimed to reveal the impact of KMC on FI in preterm infants. | PMC10407975 | |
Methods | The population of the study, designed as a randomized trial, consisted of 168 preterm infants [KMC: 84, Standart Care (SC): 84] hospitalized in the neonatal intensive care unit of a university hospital between June and November 2020. Infants were randomly selected and divided into two groups. After the vital signs of the infants in both groups became stable, the infants were fed in the same position. KMC was applied to the infants in the intervention group for 1 h by preparing a suitable environment after feeding. Infants in the SC group were placed in the prone position after feeding. The GRVs of the infants in both groups were recorded on the Infant Follow-up Form before the next feeding. | PMC10407975 | ||
Results | No statistically significant difference was detected between the groups upon comparing them in terms of demographic and clinical characteristics. The body temperatures and O | PMC10407975 | ||
Conclusion | The present study demonstrated that KMC had a positive impact on FI in preterm infants. KMC is not only a safe care model providing the earliest contact between parents and infants but also a practice whose positive effect on the functioning of the digestive system in preterm infants we can use. | PMC10407975 | ||
INTRODUCTION | Enteral feeding plays an essential part in the survival of preterm infants [Feeding-related nursing care has been accepted as a key factor in increasing the survival rates, health and development of infants with special care needs [Kangaroo mother care (KMC) is a care approach within the scope of developmental care theory, which is used the most to support these infants, and it has many physiological and behavioral benefits [ | PMC10407975 | ||
METHODS | PMC10407975 | |||
Study design | The research was designed as an experimental trial to demonstrate the effects of KMC on FI in preterm infants. The study population comprised all preterm infants ( | PMC10407975 | ||
Sample selection criteria | breast milk, neurological disease | NEUROLOGICAL DISEASE | Preterm infants who were born between 28 and 36 gestational weeks determined according to the time of mothers' last menstruation and obstetric evaluation results, had low birth weight (weighed between 1000 and 2500 g) during the research, had stable vital signs and could consume 75% of the total protein and energy through an orogastric (OG) tube, were fed with breast milk and eoprotein, did not use muscle relaxants, analgesics, sedatives or inotropic drugs, did not have a severe neurological disease and breathed spontaneously were included in the study. KMC was applied by non-smoking mothers volunteering to take part in the research. | PMC10407975 |
Exclusion criteria | NEC, skull fracture, atelectasis | GASTROINTESTINAL DISEASES, ATELECTASIS | Intubated preterm infants without cardiorespiratory stabilization and with pneumothorax, vomiting or bilious-stained gastric aspirate, other gastrointestinal diseases, NEC, skull fracture, severe atelectasis or a history of surgery that might impact their comfort, and a condition that prevented the placement of a chest tube or parent's/infant's KMC position were not included in the research. Furthermore, mothers not speaking Turkish were not enrolled in the study.Power analysis was performed in the G*Power (3.1.9.2) program for the purpose of finding the sample number. The effect size (d) of 0.555 was computed using the mean (0.9 and 2.0) and standard deviations (1.6 and 2.3) obtained from the relevant literature [Flow chart of research.The urn method, which represents a method of randomization that is equivalent to the full randomization method, was employed to ensure the randomization of the groups. Two parameters, | PMC10407975 |
Data collection | To collect the study data, the Descriptive Information Form, KMC Follow-up Form, and GRV Measurement Form were used. | PMC10407975 | ||
Descriptive information form | The form in question contains the descriptive information (age, weight, sex, etc.) of the mother and the infant. | PMC10407975 | ||
KMC follow-up form | Information such as the date of starting KMC, vital signs measured before and after KMC, and the amount of residue (ml) measured before the next feeding (approximately in a 3-h period) is recorded. | PMC10407975 | ||
GRV measurement form | vomiting, abdominal distention | ‘FI’ represents a combination of clinical signs that suggest that an individual cannot tolerate enteral feeding. The most comprehensive definition is presented below: It is the inability to digest more than 50% of enteral feeding presented as GRV, abdominal distention or vomiting, or both of them, and thus disruption of the patient’s feeding plan [An OG or nasogastric (NG) tube suitable for the week of gestation was inserted at the time of hospitalization. In the current research, preterm infants were fed by the intermittent feeding method every 3 h; the feeding time was 30 min with a pump. GRV was checked in infants with abdominal distention or vomiting before the previous feeding (measuring the gastric content after feeding and resting using an injector), and residuals >50% and/or bloody residues were considered FI. | PMC10407975 | |
Procedure | hand-foot, NEC, shock, congenital malformations, Breast milk, Breast milk fortification, respiratory distress, breast milk, obstructions | MULTIPLE ORGAN FAILURE, DYSFUNCTION, SHOCK | Before including them in the study, the researcher met with the family and the infant. The study's aim and KMC application were explained to the family. An informed consent form was given to the families who wanted to take part in the study, and the family read it and approved it. The infant's group was determined according to the urn method. The Mother and Infant Descriptive Information Form among the data collection forms was filled out.All interventions in the KMC and SC groups were performed by two independent observers simultaneously, YÇ (also a nutrition nurse) and MS (also an infant care nurse), who are among the study authors and are currently working in the day shift in the Neonatal Intensive Care Unit.Enteral (with OGT/NGT) nutrition is started in preterm infants with a gestational age of <3234 weeks, with sucking/swallowing dysfunction, or who cannot be fed orally. If the infant's weight is between 1000 and 1500 g, it is increased to feed the infant as 15–20 ml/kg/day (for 1–2 days) and then 30 ml/kg/day every 2–3 h. If the infant's weight is between 1500 and 1800 g, he/she is fed as 20 ml/kg for 1 day and then 30 ml/kg/day every 3 h. Breast milk fortification is initiated when feeding reaches 50–100 ml/kg (recommended 80 ml/kg) [The breast milk of mothers with premature babies may be insufficient in the first days. Therefore, as breast milk increases, the formula is stopped and the mother's expressed breast milk is enriched with eoprotein. In order to evaluate the effect on the infant's feeding tolerance, KMC was performed when the mother's milk reached a sufficient level for her baby (15–20 cc breast milk in each expressing) (72 h after the earliest birth). Hence, KMC was carried out while infants were fed only with breast milk. Minimal enteral nutrition is started with colostrum. Breast milk is expressed at least 6 times, preferably 8–12 times, and given to the infant with an OG/NG tube.Enteral feeding is stopped in case of severe respiratory distress (respiratory rate>80/min), GIS obstructions due to congenital malformations, diagnosis of NEC, hemodynamics, irregularity and shock requiring high inotropic treatment support, or multiple organ failure.Infants in both groups were fed in the supine position with their heads raised at 30–45° after the position control in preterm infants with an OG or NG tube inserted.Before the procedure, eoprotein was added to the breast milk of the preterm infant (one measure of eoprotein to 25 cc of breast milk) and heated in a standard food warmer. Feed volumes were the same for each infant.The vital signs of the infants in both groups were checked before feeding, and the study was continued with stable (heart rate 100–160 beats/min, respiration rate <60/min, and axillary temperature 36.5–37.4°C) infants [KMC was applied to the infants in the intervention group with stable vital signs after feeding for 60 min [Overall mean time for initiate KMC is 3.74 ± 0.79 days (min: 3, max: 5)]. KMC is the practice of placing an infant with only a hat and diaper on the parent's open chest in a prone, upright position (approximately 45°) and providing skin-to-skin contact.KMC was applied on one of the visiting days at 14.00. Attention was paid to the mother's privacy.In the hospital routine, a nest is created with rolled up cloths in the incubator (the newborn's hand-foot coordination is supported by the nest, and stress and energy consumption are reduced due to a decrease in swaying and involuntary movements).To ensure homogeneity between the groups and evaluate the effectiveness of KMC, while infants in the intervention group received KMC after feeding, infants in the SC group were placed in the prone position after feeding. The prone position after feeding is currently practiced in infants receiving standard care in the ward. When studies assessing the effect of the position given after feeding on GRV in newborns are reviewed, it has been proven that the prone position is superior to other positions with low GRV and high nutrient absorption probability [Infants in the standard care group were placed in the prone position after feeding.YÇ and MS checked vital signs after 60 min in both groups. They evaluated the residual volume of infants in both groups prior to the next feeding (approximately 3 h later).All interventions were performed under the same environmental conditions (quiet, calm and low-lit environment). | PMC10407975 |
Ethical considerations | The study was approved by the Clinical Studies Ethics Committee of Kahramanmaraş Sütçü İmam University in Turkey (Date: 2020/24, Decision No: 03). Written informed consent was obtained from all participants before enrollment into the study. | PMC10407975 | ||
STATISTICS | In the research, the data of 168 participants were assessed and transferred to IBM SPSS Statistics 23 program on the computer. The participants' descriptive characteristics were analyzed with frequency ( | PMC10407975 | ||
RESULTS | weight gain | When the participants in the KMC and SC groups were compared in terms of some descriptive and clinical characteristics, the groups did not differ statistically significantly (Comparison of some descriptive and clinical characteristics by groups
When the participants in the groups were compared in terms of pre-feeding body temperatures, respiratory rates, OComparison of vital signs, weight gain, feeding and length of hospital stay in preterm newborns by groups
Paired sample P-values indicate significance <0.05 are represented in Bold.P-values indicate significance < 0.001 are represented in Bold.Upon comparing the participants in the KMC and SC groups according to the presence of FI, a statistically significant difference was revealed between the groups (Comparison of feeding intolerance in preterm newborns by groups
P-values indicate significance <0.05 are represented in Bold.P-values indicate significance < 0.001 are represented in Bold. | PMC10407975 | |
DISCUSSION | volume and gastric emptying, breast milk, abnormal feeding and disorders, weight gain, gastrointestinal dysfunction | DISEASE, GASTROINTESTINAL DYSFUNCTION | FI represents a group of clinical symptoms of abnormal feeding and disorders caused by gastrointestinal dysfunction due to different disease factors in the neonatal period [Nutrition care is one of the primary measures to save preterm infants. In this regard, proper positioning is one of the key measures that is done by nurses; still there is a paucity of studies on the impacts of different body positions applied to preterm and low birth weight infants on residual gavage volume and gastric emptying time and the results of these few studies are an area of ongoing debates [When the infants were compared their vital signs, weight gain, feeding, and length of hospital stay, it was determined that the transition time to full enteral feeding was statistically significantly shorter in the infants in the KMC group in comparison with the SC group. Additionally, the participants in the KMC group had higher body temperatures and OThere were also some limitations of this study. First, FI in preterm infants is affected by multiple risk factors, including race, history of abnormal Doppler’s in pregnancy, some environmental factors that may alter the infant's bacterial flora/antibiotic use and the infant's diet. This study neglected the influence of these confounding factors. In addition, although only those who breastfed were included, the variability in the content of breast milk and the formula they used in the first days may also have affected the FI. Finally, this study has been performed in only one center.In conclusion, KMC affected FI in preterm infants. During feeding, infants can be placed in the KMC position so that they benefit from maternal care while benefiting from the positive effect of this upright position on the digestive system’s functioning. In line with the findings and limitations of the current research, it is recommended to compare the effects of KMC with different positions in preterm infants in the NICU. | PMC10407975 |
FUNDING | None. | PMC10407975 | ||
REFERENCES | PMC10407975 | |||
Aims | hip arthroplasty, THA | This article aimed to explore the efficacy of robotic arm-assisted total hip arthroplasty (THA) in improving preoperative planning and intraoperative decision-making. | PMC10440908 | |
Methods | THA | In this single-center, prospective, randomized clinical controlled trial, 60 patients were randomly divided into two groups: conventional THA (cTHA) and robotic arm-assisted THA (rTHA). The rTHA underwent procedures using a robot-assisted surgical system, which generated three-dimensional models to determine the most appropriate prosthesis size and position. The standard process of replacement was executed in cTHA planned preoperatively via X-ray by experienced surgeons. Differences between predicted and actual prosthetic size, prosthetic position, and leg length were evaluated. | PMC10440908 | |
Results | anemia | ANEMIA | Sixty patients were included in the study, but one patient was not allocated due to anemia. No significant preoperative baseline data difference was found between the two groups. The actual versus predicted implantation size of both groups revealed that 27/30 (90.0%) in the rTHA group and 25/29 (86.2%) in the cTHA group experienced complete coincidence. The coincidence rate for the femoral stem was higher in the rTHA group (83.3%) than that in the cTHA group (62.7%). Between the actual and predicted rTHA, the difference in anteversion/inclination degree (< 6°) was largely dispersed, while cTHA was more evenly distributed in degree (< 9°). The differences in leg length between the surgical side and contralateral side showed a significant deviation when comparing the two groups ( | PMC10440908 |
Conclusion | Robotic arm-assisted total hip arthroplasty can be valuable for preoperative planning and intraoperative decision-making. | PMC10440908 | ||
Keywords | PMC10440908 | |||
Introduction | hip joint diseases, THA, pain | COMPLICATIONS | Total hip arthroplasty (THA) is an effective method for advanced hip joint diseases. At present, the main purpose of THA is to reduce pain and improve the function of the hip joint. Globally, there are more than 1 million THAs every year, and the number is increasing yearly [With the increasing types of prostheses, THA has significantly grown in complexity over time. Inappropriate placement will not only affect the stability and bone integration and increase the probability of complications after THA [The X-ray template or digital two-dimensional template is a commonly used method for preoperative planning. It predicts the size and position of the prosthesis with an accuracy of 78–95% [In this study, an independently developed manipulator-assisted robot was used for preoperative planning and compared with conventional two-dimensional digital X-ray planning. The purpose of this study was to focus on whether robotic arm-assisted THA (rTHA) can improve preoperative planning compared to conventional THA (cTHA). Besides, the improvement of intraoperative decision-making between the two groups was also explored in this study. | PMC10440908 |
Materials and methods | neuromuscular dysfunction, dysplasia, anemia, paralysis, hip arthroplasty, infection, bony ankylosis, arthroplasty, hip deformity | DYSPLASIA, ANEMIA, WEST, INFECTION, DISEASES, ANKYLOSING SPONDYLITIS | This study was a single-center (Orthopedics, West China Hospital, Chengdu, China), prospective, randomized clinical controlled trial including participants aged 18–80 years old. This trial was approved by the Ethics Committee on Clinical Trials, West China Hospital of Sichuan University (HX-IRB-AF-12-V4.0). All patients provided written informed consent before participation. The study was registered in the Clinical Trial Registry (ChiCTR2200059968). The exclusion criteria were as follows: neuromuscular dysfunction, including paralysis, myolysis or abductor weaknes; active infection lesions; severe hip deformity and hip dysplasia with Cone grade 3 or 4; ankylosing spondylitis patients with bony ankylosis or severe stiffness; bilateral hip arthroplasty at the same time; severe internal and surgical diseases or weak physique; and poor expected compliance. In total, 67 potential test persons were scheduled to undergo primary THA, where 4 patients were ineligible and 3 patients declined participation. The remaining 60 patients were randomized into two groups, while 1 patient in the cTHA group was finally not allocated due to anemia (Fig. Consolidated standards of reporting trial (consort) diagram showing the flow of patients through robotic arm-assisted total hip arthroplasty (rTHA) versus conventional total hip arthroplasty (cTHA) | PMC10440908 |
Randomization | The interactive network response system Clinflash IRT v2.2.10 (Clinflash Healthcare Technology, Jiaxing Clinflash Computer Technology Co. Ltd.) automatically distributed groups randomly according to the order of entry to reduce the test bias caused by sampling error. The random table was generated by the specified person, and the random table was generated by SAS version 9.4 (SAS Institute, Cary, NC) according to the preset number of seeds and the number of blocks. The ratio of the trial group to the control group was 1:1 by using the block randomization design according to central stratification. Any subjects who had completed randomization but withdrew from this clinical trial before the commencement of treatment were retained. | PMC10440908 | ||
Intervention | femoral head, THA | A total of 60 patients were randomly divided into two groups: patients who underwent conventional THA (cTHA group) and patients who underwent robotic arm-assisted THA (rTHA group). The patients in the cTHA group underwent preoperative planning, during which the pelvic digital X-ray (enlarged by 100%) was compared to a two-dimensional digital model of the prosthesis. Conversely, patients undergoing rTHA had preoperative CT scans of the pelvis and both knees, in which the pelvic CT was compared to a three-dimensional digital model of the prosthesis using a robotic navigation system for precise implant positioning (Fig. Preoperative planning with computer for robotic arm-assisted total hip arthroplasty. 手术规划, surgical planning; 髋臼杯, acetabular cup; 内衬, acetabular liner; 球头, femoral head; 柄类型, stem type; 股骨柄, femoral stem | PMC10440908 | |
Outcome measures | All patients were examined by X-ray and CT within 14 days before surgery. One day before the operation, the planning for the cTHA group was based on X-ray measurements of the size and position of the prosthesis and the length of the lower extremities. The length was determined by drawing a horizontal reference line through bilateral tears and measuring the distance from the vertex of the surgical and contralateral lesser trochanter to the horizontal reference line (Fig. Presenting the process of calculating the length of both lower limbs. A. Bilateral tear drop line; B. Distance from the left lesser trochanter to the tear drop line; C. Distance from the right lesser trochanter to the tear drop line | PMC10440908 | ||
Statistical analysis | SPSS 27.0 (IBM, Chicago, IL, USA) was used for data analysis. Data were reported as the means and standard deviations or as proportions. The independent-samples t-test was used for continuous data showing a normal distribution, the Mann‒Whitney U test was used for continuous data showing skew, and the chi-squared test or Fisher precision test was used for categorical data. A two-sided | PMC10440908 | ||
Discussion | scoliosis, low back pain, THA | SCOLIOSIS, COMPLICATIONS, POSTOPERATIVE COMPLICATIONS | In this prospective randomized clinical controlled trial, the purpose was to investigate the impact of preoperative planning and intraoperative decision-making caused by rTHA. Our results show that compared with cTHA, rTHA reduces leg length difference in lower limbs, and shows similar predictive effects of the size and position of the prosthesis as the experienced orthopedic surgeons, which reflects the relatively strong ability in preoperative planning and intraoperative decision-making.An inaccurate size of the prosthesis can lead to serious intraoperative and postoperative complications and may even lead to the failure of THA [The placement of prostheses in traditional THA mainly depends on the experience of the operators. We assume that the placement of acetabular prostheses can be better guided by rTHA. In our results, we use the angular difference of the acetabular cup between the actual and predicted values to comprehensively reflect the ability of preoperative planning and intraoperative decision-making of our robot. Our results show that the inclination/anteversion differences contained a similar trend, that is, rTHA is more often located in groups (< 6°), while cTHA is more widely distributed across all four groups. This implies that the actual angles deviate more from the planned angles in cTHA, suggesting that rTHA can reduce the placement error of the prosthesis and make the prosthesis reach the desired position as much as possible. Accurate matching between the prosthesis and the patient can be realized in three-dimensional view intraoperatively, and the error caused by the measuring instrument and the human can be effectively reduced. The robotic system can identify the surgical situation accurately, adjust in a timely manner, and finally make correct intraoperative decision-making during the operation.The ideal leg length difference after THA is less than 1 cm, while conversely, it will lead to a series of complications, such as scoliosis, low back pain, and worn prostheses [The study has some limitations. First, as a prospective study, this trial selected only 60 patients, a small number of cases, and requires a larger sample to obtain clearer results. Second, although the robot planning navigation system was compared with the traditional X-ray template, this trial did not use a 3D template as a control. Third, CT scanning was performed by a robot planning navigation system before the operation, whose radiation dose and economic cost increase compared with the control group. Fourth, although there was no significant difference in BMI between the two groups, the closeness to significant difference may introduce some bias. Fifth, while the surgeons made efforts to adhere to the initial plan during the surgical procedure, it is possible that adjustments were made to the implant positions based on intraoperative findings and considerations, for both groups. This could introduce a slight margin of error in the experiment. Sixth, during preoperative planning, the rTHA group utilized anatomical inclination/anteversion angles for their planning, while the cTHA group used radiographic inclination/anteversion angles. This difference in approach is a result of the designed system differences and introduces potential bias to the experiment. | PMC10440908 |
Acknowledgements | We would like to thank the surgeons, nurses, and research staff at our joint center for their support. | PMC10440908 | ||
Author contributions | HPL and QX: drafted the work and provided critical revision for important intellectual content. HPL and HX: performed data collection, analysis, and interpretation. TFY: participated in final approval of the version to be published. ZKZ: contributed to the conception and design of the study, and revised the manuscript. All authors read and approved the final manuscript. | PMC10440908 | ||
Funding | This study was supported by Key Research & Development Program of the Science & Technology Department of Sichuan Province (2021YFS0125), Regional Innovation & Cooperation Program of the Science & Technology Department of Sichuan Province (2021YFQ0028). The funders had no role in study design, data collection, data analysis, decision to publish, or preparation of the manuscript. | PMC10440908 | ||
Declarations | PMC10440908 | |||
Ethics approval and consent to participate | WEST | The hospital’s institutional review board approved the study. A statement of the location where the work was performed: The work was performed in Department of Orthopaedic surgery, West China Hospital, Sichuan University. | PMC10440908 | |
Competing interests | No competing interests exits in the submission of this manuscript, and manuscript is approved by all authors for publication. | PMC10440908 | ||
References | PMC10440908 | |||
Background | Healthcare-associated infections | COMPLICATION | Healthcare-associated infections (HAIs) are a common, costly, yet largely preventable complication impacting patients in healthcare settings globally. Improving routine cleaning and disinfection of the hospital environment has been shown to reduce the risk of HAI. Contaminated shared medical equipment presents a primary transmission route for infectious pathogens, yet is rarely studied. The CLEEN study will assess how enhanced cleaning and disinfection of shared medical equipment affects the rate of HAIs in a tertiary hospital setting. The initiative is an evidence-based approach combining staff training, auditing and feedback to environmental services staff to enhance cleaning and disinfection practices. | PMC9944767 |
Methods | SECONDARY | The CLEEN study will use a stepped wedge randomised controlled design in 10 wards of one large Australian hospital over 36 weeks. The intervention will consist of 3 additional hours per weekday for the dedicated cleaning and disinfection of shared medical equipment on each ward. The primary outcome is to demonstrate the effectiveness of improving the quality and frequency of cleaning shared medical equipment in reducing HAIs, as measured by a HAI point prevalence study (PPS). The secondary outcomes include the thoroughness of equipment cleaning assessed using fluorescent marker technology and the cost-effectiveness of the intervention. | PMC9944767 | |
Discussion | infection | INFECTION | Evidence from the CLEEN study will contribute to future policy and practice guidelines about the cleaning and disinfection of shared medical equipment. It will be used by healthcare leaders and clinicians to inform decision-making and implementation of best-practice infection prevention strategies to reduce HAIs in healthcare facilities. | PMC9944767 |
Trial registration | Australia New Zealand Clinical Trial Registry ACTRN12622001143718. | PMC9944767 | ||
Keywords | PMC9944767 | |||
Administrative information | WEST, MITCHELL | Note: the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see This project is funded by an NHMRC Emerging Leadership Investigator grant (Prof Brett Mitchell), (GNT2008392), administered by Avondale University.Academic and clinical project partners at Cabrini Health, Monash University, Alfred Health the Queensland University of Technology and Central Coast Local Health District.Industry partners GAMA Health Care may provide tools to support data collection and education. They have no role in the study design, implementation, analyses, interpretation or publications.
Avondale UniversityUniversity of NewcastleMonash UniversityCentral Coast Local Health District
Cabrini HealthMonash University
Queensland University of Technology
Central Coast Local Health District
Avondale UniversityMonash University
Avondale University
Monash UniversityAlfred Health
Monash UniversityAlfred Health
Central Coast Local Health District
NSW Health Pathology
Central Coast Local Health DistrictUniversity of Newcastle
University of West LondonAvondale University
Queensland University of TechnologyAvondale UniversityContact: Prof Brett MitchellBrett.mitchell@avondale.edu.au | PMC9944767 | |
Introduction
| PMC9944767 | |||
Background and rationale {6a} | infection, infections, healthcare-associated infections | INFECTION, INFECTIONS, EMERGING INFECTIOUS DISEASE | One in 10 patients in an Australian hospital will acquire an infection while in the hospital (1). This equates to approximately 170,000 infections each year (2). These hospital-acquired infections represent just a subset of the total number of healthcare-associated infections (HAIs), which include infections associated with receiving healthcare in all settings. The burden of HAIs is significant, with increased levels of morbidity and mortality and, for those acquired in hospitals, increased length of stay (2,3). However, there is little level 1 evidence into the role of environmental cleaning to reduce HAIs (4,5). Prevention of infections through practical, implementable and translatable interventions is of critical importance in the era of antimicrobial resistance. These strategies will not only reduce the burden and impact for patients and health services in the short term, but also contribute to limiting antimicrobial resistance and better prepare healthcare settings for emerging infectious disease threats.Contaminated healthcare environments provide a reservoir for pathogens to be transmitted to patients. Admission to a hospital room previously occupied by a patient infected and/or colonised with a specific pathogen is a major risk factor for acquisition (6). This means that a primary transmission route of pathogens is via the patient environment. A seminal study published in 2020, conducted in 11 Australian hospitals (REACH study), demonstrated improvements in routine hospital cleaning being associated with a reduction in infections (7). This research was the first cluster randomised control trial (RCT) to evaluate the effect of a cleaning and disinfection bundle that focuses on routine and discharge hospital cleaning on the incidence of HAIs. The REACH study did not, however, focus on the cleaning of shared medical equipment. This is a significant lacuna because infectious pathogens have been identified on shared medical equipment (8). Another Australian study published in 2018 demonstrated through whole genome sequencing that shared medical equipment also plays a critical role in the transmission of infection (8). This proposed trial builds on the REACH study findings, including important implementation strategies, and focuses on improving the cleaning and disinfection of shared medical equipment as a key strategy in the reduction of HAIs. | PMC9944767 |
Objectives {7} | Objective 1: Assess the effectiveness of improving the quality and frequency of cleaning and disinfection of shared medical equipment in reducing HAIs.Objective 2: Evaluate the cost-effectiveness of the intervention. | PMC9944767 | ||
Trial design {8} | This study is a stepped wedge randomised controlled study, conducted in 10 wards of one acute Australian hospital over 36 weeks. A stepped wedge design allows all wards to receive the intervention at different times, with each ward acting as its own control. Each cluster will comprise two wards. One cluster will switch to the intervention every 6 weeks. This study design reduces the influences of confounders such as variations in size and case mix and supports feasibility while maintaining rigour. This design also allows research staff to work with individual wards as they adopt the intervention, maximising consistency of intervention and aiding implementation (Fig. The stepped wedge study design. Green (dotted) = control, blue (striped) = intervention | PMC9944767 | ||
Methods: participants, interventions and outcomes | PMC9944767 | |||
Study setting {9} | One Australian hospital that meets the eligibility criteria will be enrolled in the study. Ten wards within the hospital will be selected for the study. | PMC9944767 | ||
Eligibility criteria {10} | ’ | The eligible hospital will meet the following criteria: classified as a ‘Public acute group A hospital’ by the Australian Institute of Health and Welfare (9), located in New South Wales, have an intensive care unit, have a minimum of 10 wards, and caring for adult patients (i.e. ≥ 18 years old) willing to participate in the study. Ten wards with > 20 beds, caring for adult patients, will be selected for the study.Hospitals will be excluded from the study if they do not meet the inclusion criteria. Hospitals may also be excluded from the study if within the study time frame (2023–2024) they are opening, closing or relocating, or implementing major environmental cleaning initiatives or changes. | PMC9944767 | |
Who will take informed consent? {26a} | infections, healthcare-associated infections | INFECTIONS | This project collects data associated with human beings only. Data from all patients (> 18 years old) who are inpatients on one of the 10 wards on the day of the PPS will be used. As this project collects data associated with human beings only, there is no consent process and a waiver of consent has been sought and granted by the authorising Human Research Ethics Committee (HREC). The approach taken in this study with respect to a waiver of consent is consistent with other multi-centre studies where a point prevalence study of healthcare-associated infections has been undertaken as the primary outcome (and data collection method) and ethics approval has been granted (1,10,11). Similarly, our approach is consistent with stepped wedge trials with infections as the outcome and interventions that posed low risk and collected data from existing records. In these instances, a waiver of consent was granted.There are no interventions and no harm or discomfort to the patient as a result of the project. The benefits of the research justify any risk of harm associated with not obtaining consent. Results of the research are not individualised or patient identifiable. The study requires no direct involvement of patients; rather, it collates existing information obtained during their hospitalisation. No new information will be obtained about individual patients; therefore, results will have no significance for the individual welfare of patients. | PMC9944767 |
Additional consent provisions for collection and use of participant data and biological specimens {26b} | Not applicable—no biological specimens will be collected for this study. | PMC9944767 | ||
Interventions | PMC9944767 | |||
Explanation for the choice of comparators {6b} | FM | The stepped wedge study design allows each ward to act as its own control. During the control phase, the cleaning and disinfection of shared medical equipment are undertaken by PSAs according to hospital policies. The intervention phase introduces 15 additional hours per week, purely dedicated to the cleaning and disinfection of shared medical equipment. During the intervention phase, PSAs will be educated on correct cleaning and disinfection technique. To confirm equipment is being properly cleaned during the intervention, auditing with fluorescent markers (FM) will allow feedback to PSA staff. This design allows the comparison between routine (control) and enhanced (intervention) disinfection. | PMC9944767 | |
Intervention description {11a} | The intervention will consist of additional time dedicated to cleaning and disinfection of shared medical equipment, education on cleaning technique, auditing of cleaning efficacy and feedback on cleanliness to staff. This multimodal strategy to improve the cleaning and disinfection of shared patient equipment is grounded in the literature and recent research (7,12). The primary target for the intervention is the cleaning staff. | PMC9944767 | ||
Additional cleaning | During the intervention phase, each trial ward will receive an additional 3 h of cleaning per weekday by dedicated cleaners. This is in addition to routine cleaning that already occurs. The use of dedicated cleaners will reduce the risk of contamination and assist in consistency in implementation. An expression of interest process will be used to identify cleaners who are seeking additional work. This will be managed and handled by the participating hospital, in line with enterprise bargaining arrangements and local policy.The additional cleaning will focus on specific shared medical equipment (Table Focus of additional cleaningAutomatic machinesAreas to be cleaned are cuff, buttons, OSurfaces to be cleaned include:• Horizontal surfaces• Keyboards• Vertical surface and pedestalsDailyDailyWeekly^Note that if time allows, other equipment will include trolleys, bladder scanners (cleaning probe and buttons), patslides (those in shared areas/storage only), resuscitation trolleys (top surface and drawers—outside only) and medication trolleys | PMC9944767 | ||
Education | The dedicated cleaners undertaking the additional cleaning will undergo education and training sessions prior to the commencement of the intervention. Education prior to the invention will include at least a 1-h in-service, where cleaning techniques will be taught and practised. This will occur no longer than 2 months prior to the commencement of the intervention. The training will be delivered by staff experienced in education and cleaning practice. Standard operating procedures for cleaning specific items of shared medical equipment will be developed and subsequently explained at the in-service (if they are not already in existence at the hospital). These will also be readily available for staff for future reference as needed. | PMC9944767 | ||
Audit and feedback | dry abrasion, Infection, FM | INFECTION | The benefits and role of audit, including the use of fluorescent markers (FM), in assessing environmental cleaning, is well documented (7,13,14). Audit and feedback to the cleaning staff involved in the additional cleaning will include the use of FM technology, in which invisible gel dots that are removed by cleaning are applied to surfaces. The dots are invisible to the naked eye, resist dry abrasion, and are removed completely by routine cleaning. A structured auditing approach, with staff feedback underpinned by education, will aid improvements in cleaning, as shown in multiple studies (7,13,14). FM auditing of shared equipment will be conducted fortnightly in each ward.During the intervention phase, audit results will be reported verbally to the cleaning staff, with a follow-up email to cleaning supervisors and the Nursing Unit Managers. Audit results will be used to inform further informal face-to-face education and training. In discussing audit results, informal goals for the next audit will be set with the cleaners. Additional reports will be provided for internal committees, such as the Infection Prevention and Control committee at the conclusion of the study. | PMC9944767 |
Criteria for discontinuing or modifying allocated interventions {11b} | The study will be discontinued if a regulatory body, funding body or the HREC judges it necessary for medical, safety, regulatory or other reasons consistent with applicable laws, regulations and good clinical practice. | PMC9944767 | ||
Strategies to improve adherence to interventions {11c} | FM | To improve adherence to intervention protocols, there will be educational training sessions that focus on correct cleaning techniques. Refresher training sessions for PSAs will be held during the intervention period to promote correct cleaning and disinfection techniques. The study coordinator will have regular communication with PSAs (fortnightly) where the results of the FM audits will be communicated to PSA staff to help improve the quality of cleaning and disinfection. During the intervention phase, PSAs allocated to additional cleaning hours will have daily communication with Nursing Unit Managers. | PMC9944767 | |
Relevant concomitant care permitted or prohibited during the trial {11d} | Not applicable—as there is no direct intervention for patients. | PMC9944767 |
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