Saturation Targets and Resuscitation in Preterm Infants the Delivery Room: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change in Oxidative Balance Ratio from Baseline
研究概览
简要总结
The purpose of this research project is to determine if use of optimized target oxygen strategy during delivery room resuscitation can reduce oxidative stress in premature newborns. Objective is to compare oxidative stress markers between preterm neonates resuscitated in the delivery room using three different target oxygen strategies. OX50 target oxygen strategy is currently in use and recommended by neonatal resuscitation program. In this strategy oxygen is adjusted to meet the goal transitional saturations which are approximated 50th centile saturations observed in healthy term newborns. In OX25 target oxygen strategy oxygen will be adjusted to meet the goal transitional saturations which are 25th percentile transitional saturations observed in healthy term newborns. In OX75 target oxygen strategy oxygen will be adjusted to meet the goal transitional saturations which are 75th percentile transitional saturations observed in healthy term newborns.
详细描述
Study Design: A prospective randomized controlled trial of OX50 versus OX25 versus Ox75 will be conducted at Parkland Hospital. This study will test the hypothesis that the OX25 target oxygen strategy will result in successful resuscitation of preterm neonates with less O2 exposure and reduction in oxidative stress compared to the currently recommended Ox50 target O2 strategy and novel OX75 target oxygen strategy.
Study Population: Neonates with obstetric gestational age (GA) of 23-30 weeks, born at Parkland Hospital, Dallas, TX, who require active resuscitation, will be included. Active resuscitation is defined as positive pressure ventilation (PPV), continuous positive airway pressure (CPAP), or ventilation via an endotracheal tube.
Outcomes:
A. Primary outcome:
• Increase in oxidative balance ratio from baseline by 20%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Clinical care team in the neonatal intensive care unit, investigators running the oxidative stress measurements and investigator assessing neurodevelopmental outcomes will be blinded to which arm the infant was randomized to in the delivery room.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates of obstetric gestational age 23-30 weeks
- •Inborn at Parkland Hospital, Dallas, Tx
- •Resuscitation team present to initiate resuscitation
排除标准
- •Prenatally diagnosed cyanotic congenital heart disease
- •Prenatally diagnosed congenital diaphragmatic hernia
- •Prenatally diagnosed significant airway anomaly
- •Prenatally suspected hypoplasia of lungs
- •Preductal saturation cannot be measured
- •Non-viable newborns
- •Prenatally diagnosed condition due to which decision is made to limit resuscitation in the delivery room by parents and neonatologist.
结局指标
主要结局
Change in Oxidative Balance Ratio from Baseline
时间窗: within 2 hours after Birth
Difference in oxidative balance ratio between Cord blood and postnatal sample obtained within 2 hours of life will be assessed.
次要结局
- Incidence of bradycardia during resuscitation(During resuscitation in the delivery room)
- Time spent in goal saturations(During resuscitation in the delivery room)
- intubation in the delivery room(During resuscitation in the delivery room)
- Reduction in Isoprostane,Isofluran, 8-OHdG and protein carbonyls(Within 2 hours after birth and at 24 hours)
- Neurodevelopmental Impairment(Within 2 years)
- Necrotizing enterocolitis (NEC)(within 6 months)
- Retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), Grade 3/4 intraventricular hemorrhage (IVH), Mortality during NICU stay(Within 1 year)
- Mortality(within 2 years)
- Grade III/IV Intraventricular hemorrhage(within 6 months)
- • Reduction in oxygen load in the delivery room(During resuscitation in the delivery room for the first 15 minutes of life)
- Bronchopulmonary dysplasia (BPD)(within 6 months)
研究者
Vishal Kapadia
Assistant Professor of Pediatrics
University of Texas Southwestern Medical Center