DELIVERY ROOM RESUSCITATION OF PRETERM NEONATES WITH ROOM AIR VERSUS 100 % OXYGEN: A BLINDED RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- PGIMER
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Plasma 15-F2t-isoprostane levels
研究概览
简要总结
This is a randomized controlled trial with blinding in preterm neonates 28 to 33 6/7 weeks gestation needing resuscitation at birth to study whether resuscitating them with room air (21% oxygen) decrease the plasma 15-F2t-isoprostane levels (measure of oxidative stress) at 4 hours of life by at least 30% in comparison to 100% oxygen. This study will be conducted in a single center in India and has planned to enroll 124 preterm neonates for this purpose after obtaining an informed written consent. The primary outcome measure will be Plasma 15-F2t-isoprostane levels at 4 hours of life. The major secondary outcomes will be Plasma 15-F2t-isoprostane levels at 72 hours of life, MDA levels at 4 hrs and 72 hours of life, Blood gas parameters (pH, pO2, pCO2, SBE) at 1,4,12 and 24 hours of life, Apgar scores at 5, 10, 15 and 20 minutes of life, Time to normalization of heart rate (>100/minute), heart rate and SpO2 changes in first 30 minutes of life, Time to first breath, Time to achieve regular respiration, Mortality till 40 weeks of postmenstrual age, Incidences of hypoxic ischemic encephalopathy (HIE), Bronchopulmonary dysplasia (BPD), and retinopathy of prematurity (ROP), duration of oxygen, duration of ventilation, abnormal neurological examination at 40 weeks of postmenstrual age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 0.00 Day(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria: 1) Preterm neonates 28 to 33 6/7 weeks gestation born between 8 AM to 9PM , Monday to Saturday in delivery room or operation theatre (Note: These timings have been chosen to ensure the availability of the research team for all eligible deliveries ), and 2) Needing bag and mask ventilation as per Neonatal Resuscitation Program (NRP) i.e. apnea or gasping respiration, and/or heart rate < 100/min after 30 seconds of initial steps Exclusion criteria: 1)Life threatening congenital malformations diagnosed antenatally or soon after birth 2)Antenatally diagnosed congenital heart defects 3)Concurrent delivery where the research team is already involved with delivery of another woman already enrolled in the trial.
排除标准
- •a)Life threatening congenital malformations diagnosed antenatally or soon after birth b)Antenatally diagnosed congenital heart defects c)Concurrent delivery where the research team is already involved with delivery of another woman already enrolled in the trial.
结局指标
主要结局
Plasma 15-F2t-isoprostane levels
时间窗: At 4 hours of life
次要结局
- a)Biochemical : Plasma 15-F2t-isoprostane levels, plasma MDA levels, blood gas parameters (pH, pO2, pCO2, SBE)b)Physiologic : Apgar scores at 5, 10, 15 and 20 minutes of life, Time to normalization of heart rate (>100/minute), heart rate and SpO2 changes c)Clinical : Time to first breath, Time to achieve regular respiration, Mortality, Incidences of hypoxic ischemic encephalopathy (HIE), Bronchopulmonary dysplasia (BPD), and retinopathy of prematurity (ROP), duration of oxygen, duration of ventilation, abnormal neurological examination(Biochemical - 1, 4, 12, 24 and 72 hoursPhysiologic - 30 minutesClinical - 40 weeks or earlier)