Ventilatory Management of the Preterm Neonate in the Delivery Room.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Need for mechanical ventilation for neonates on nCPAP
研究概览
简要总结
The purpose of this study is to evaluate sustained lung inflation followed by early nCPAP as delivery room ventilatory management for preterm neonates at risk of respiratory distress syndrome in reducing their need for mechanical ventilation and ameliorating lung injury without inducing adverse effects compared with intermittent bag and mask ventilation.
详细描述
Neonatal resuscitation provides lifesaving intervention that, if properly conducted, not only can reduce mortality but probably can significantly decrease subsequent morbidity.
Premature infants need appropriate respiratory support and a lung-protective strategy, starting from the delivery room where, on the contrary, an inadequate respiratory approach may influence pulmonary outcome.
Mechanical ventilation in the form of positive pressure ventilation has remained the mainstay of treatment of respiratory distress syndrome (RDS) in preterm babies. In recent years, a number of new ventilation strategies have been introduced but the problem of bronchopulmonary dysplasia (BPD) has not been solved.
Sustained lung inflation (SLI) lead to a large increase in the tidal volume and the functional residual capacity(FCR) as this intervention may influence the clearance of lung fluids and allow a more even distribution of air throughout the lungs, thus facilitating the formation of FRC.
Nasal CPAP and early PEEP act through stabilization and subsequent recruitment of collapsed alveoli, increased FRC resulting in increased alveolar surface area for gas exchange and a decrease in intrapulmonary shunt .also it conserves endogenous surfactant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 27 Weeks 至 33 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants (gestational age < 34 weeks)
排除标准
- •Neonates with major congenital anomalies (congenital heart disease, neural tube defect, trisomy, etc.).
- •2.Meconium aspiration syndrome, congenital diaphragmatic hernia and anterior abdominal wall defect.
- •3.Maternal chorioamnionitis. 4.Neonates with gestational age < 26 weeks and /or birth weight less than 750 grams.
研究组 & 干预措施
Sustained lung inflation followed by CPAP
Sustained pressure-controlled inflation using a neonatal mask and a T-piece ventilator (NeoPuff Infant Resuscitator; Fisher & Paykel, Auckland, New Zealand).
This will be followed by early CPAP.
干预措施: Resuscitation of preterm neonates by sustained lung inflation through T piece device followed by CPAP (Procedure)
Conventional self inflating bag and mask ventilation
Intermittent bag and mask ventilation using a self-inflating bag with an oxygen reservoir.
干预措施: Resuscitation of preterm neonates by intermittent bag and mask ventilation using self inflating bag. (Procedure)
结局指标
主要结局
Need for mechanical ventilation for neonates on nCPAP
时间窗: 28 days
Proportionate of neonates in each group who will need endotracheal intubation after failure of positive pressure ventilation through face mask in the delivery room.
时间窗: 2 minutes
次要结局
- Pulmonary air leaks(28 days)
- Patent ductus arteriosus (PDA).(7 days)
- Intraventricular hemorrhage (IVH).(28 days)
- Bronchopulmonary dysplasia (BPD): defined as oxygen requirements more than 28 days.(28 days)
- Necrotizing enterocolitis (NEC).(28 days)
- Delivery room death or death during admission.(28 days)
- Neonatal sepsis.(28 days)
- Occurrence and duration of oxygen therapy.(28 days)
- Length of NICU stay.(28 days)
- Inflammatory mediators before and after resuscitation(2 hours)
研究者
Dina Mohamed Mohamed Shinkar
MD
Ain Shams University