Sudden versus Gradual Weaning from NIV support in preterm neonates :- A Randomized Controlled Trial .
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Proportion of preterm neonates successfully weaned in the first attempt of weaning in each group.
研究概览
简要总结
SUMMARY OF PROTOCOL
Title: sudden versus gradual weaning from NIV Support in preterm neonates: - A Randomized controlled trial.
RATIONALE: The present study aims to test novel weaning strategies in preterm neonates on NIV support.
Primary Objective: To compare the success rate of the first attempt of successful weaning in the sudden versus gradual wean group in preterm neonates (28 to 36wk).
Secondary Objectives: To compare the following factors in the sudden versus gradual wean group: - Postmenstrual age (PMA) at the time of successful weaning and weight at the time of successful weaning. Total duration of NIV support and Length of stay (LOS) in NICU
Study Setting: Neonatal ICU (intramural) of the Department of Pediatrics of GTB Hospital, a tertiary care teaching hospital in New Delhi.
Study Period: April 2024 to Aug 2025
Study Design: A Randomized Controlled Trial.
Participants: 160 Preterm neonates (28 to 36 weeks) admitted in intramural NICU requiring NIV support.
Methods: Eligible preterm neonates in the intramural NICU of GTBH will be enrolled in the study after obtaining informed consent from parents and counselling them. Clinic-demographic data will be noted in a pre-designed case record form (CRF).
The Baby enrolled in the study undergoes randomization into the sudden versus gradual wean group and the baby is asses in each group for successful weaning. Successful weaning in each group is defined as being off oxygen for 3 days.
Primary Outcome Measures: Proportion of preterm neonates successfully weaned in the first attempt of weaning in each group.
Secondary Outcome: Mean postmenstrual age at the time of successful wean in both the group , Mean weight at the time of successful wean in both the group , Total duration of NIV support in successful weaned preterm neonates of each group, Length of stay (LOS) in NICU in successful weaned preterm neonates of each group.
Sample size: Considering the success rate of weaning in sudden is 40% (Amatya et al ) (18) and 62.8% (Amatya et al ) (18) in the gradual group. To estimate this difference in success rate at alpha error 0.05 and power = 80%, a sample of size 72 subjects is required in each group (we will take 80 subject in each group ) , which is a total of 160.
Statistical Analysis: For the primary outcome , the significance of differences in proportion successfully weaned between the groups will be tested by Chi–square Test (Fischer exact Test if applicable ) .For the secondary outcome (Mean post menstrual age , Mean weight , Total duration of NIV support , Mean length of stay in NICU ) will be compared by applying Unpaired –T-Test (Mann–Whitney Test if applicable ).
P < 0.05 will be taken as significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •All preterm neonates (28 to 36 week) on NIV Support and met the weaning readiness criteria .
- •Clinically stable neonate on NIV,PEEP of less than equal to 6cm H2O,Fio2 less than equal to 0.35percent, Maintaining Spo2 90-95percent for a minimum of 12 hours.
- •Normal work of breathing:no persistent tachypnea (more than 60 breaths for more than 2hr ),no marked retractions .
- •Hemodynamically stable .
- •4.NO APNEA associated with bradycardia or cyanosis with more than 2 episode in 12hr or more than 3 in 24hr with at least one requiring bag and mask ventilation .
- •5.Not currently treated for Patent ductus arteriosus.
- •6.Tolerated time off NIV during nursing cluster care for up to 5 to 10 minutes.
- •Pip of less than equal to 15 cm H20 and backup respiratory rate of less than equal to 50 percent of total respiratory rate.
排除标准
- •Preterm neonates with chromosomal defects and severe congenital anomalies including congenital heart disease , neurological malformations , chest wall or airway abnormalities and lung hypoplasia .
结局指标
主要结局
Proportion of preterm neonates successfully weaned in the first attempt of weaning in each group.
时间窗: Randomization to off oxygen for 3 days
次要结局
- 1. Mean post -menstrual age at the time of successful wean in both the group.(2. Mean weight at time of successful wean in both the group.)
研究者
Dr Varsha Jain
University college of medical sciences and Guru tegh bahadur Hospital ,Delhi