Sustained Lung Inflation at Birth for Preterm Infants at Risk of Respiratory Distress Syndrome: the Proper Pressure and Duration: Prospective Randomized Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The need for endotracheal intubation in the delivery room
研究概览
简要总结
The appropriate pressure and duration needed for sustained lung inflation in preterm infants at risk of respiratory distress syndrome have not been well evaluated. We aim for evaluating two different pressures, 20 and 15 cm H2O, for two different duration, 10 and 20 seconds, during the application of sustained lung inflation in the resuscitation of preterm infants with respiratory distress in the delivery room.
详细描述
This study will be a randomized prospective pilot study in Mansoura University Hospital then the cases were followed at Neonatal Intensive Care Unit in Mansoura University Children Hospital, Mansoura, Egypt.
Preterm infants born equal to or less than 32 weeks gestation with respiratory distress syndrome will be included in the study.
We aim to study the proper pressure and duration of sustained lung inflation in the delivery room.
Preterm infants will be divided into 5 groups:
- Group 1 (Control group). In this group preterm infants will not be treated with sustained lung inflation and in stead will receive regular respiratory care
- Group 2 (High pressure for long duration group). Preterm infants in this group will be treated with sustained lung inflation at pressure of 20 cm H2O for 20 seconds
- Group 3 (High pressure for short duration group). Preterm infants in this group will be treated with sustained lung inflation at pressure of 20 cm H2O for 10 seconds.
- Group 4 (Low pressure for long duration group). Preterm infants in this group will be treated with sustained lung inflation at pressure of 15 cm H2O for 20 seconds.
- Group 5 (Low pressure for short duration group). Preterm infants in this group will be treated with sustained lung inflation at pressure of 15 cm H2O for 10 seconds
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
- None
入排标准
- 年龄范围
- 1 Day 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants with gestational age ≤ 32 weeks' gestation, presented with respiratory distress syndrome at birth
排除标准
- •Preterm infants with no manifestations of respiratory distress syndrome at birth.
- •Presence of major congenital malformation (dysmorphic features or anomalies incompatible with life) .
研究组 & 干预措施
Control
Infants in this group will not receive sustained lung inflation in the delivery room and will be put immediately on CPAP at a pressure of 5 cm H2O.
High pressure for long duration
Infants in this group will receive sustained lung inflation in the delivery room at a pressure of 20 cm H2O for a duration of 20 second for a single intervention followed by CPAP at a pressure of 5 cm H2O.
干预措施: Sustained lung inflation in preterms (SLI). (Procedure)
High pressure for short duration
Infants in this group will receive sustained lung inflation in the delivery room at a pressure of 20 cm H2O for a duration of 10 second for a single intervention followed by CPAP at a pressure of 5 cm H2O.
干预措施: Sustained lung inflation in preterms (SLI). (Procedure)
Low pressure for long duration
Infants in this group will receive sustained lung inflation in the delivery room at a pressure of 15 cm H2O for a duration of 20 second for a single intervention followed by CPAP at a pressure of 5 cm H2O.
干预措施: Sustained lung inflation in preterms (SLI). (Procedure)
Low pressure for short duration
Infants in this group will receive sustained lung inflation in the delivery room at a pressure of 15 cm H2O for a duration of 10 second for a single intervention followed by CPAP at a pressure of 5 cm H2O.
干预措施: Sustained lung inflation in preterms (SLI). (Procedure)
结局指标
主要结局
The need for endotracheal intubation in the delivery room
时间窗: One hour
次要结局
- The need for mechanical ventilation(72 hours)
- Need of surfactant(72 hours)
- Neonatal mortality(90 days)
- Broncho Pulmonary Dysplasia ( BPD )(90 days)
- Intra-Ventricular Hemorrhage ( IVH )(14 days)
- Retinopathy of Prematurity ( ROP )(50 days)
- Necrotizing Entero Colitis ( NEC )(40 days)
- Length of neonatal intensive care ( NICU ) and hospital stay(90 days)
- Air-leak syndrome(14 days)
研究者
Nehad Nasef
Associate Professor
Mansoura University Children Hospital