NCT01859533已完成2 期
Positive End Expiratory Pressure With A T-piece Resuscitator (Neopuff) For Near-Term and Term Infants With Respiratory Distress: A Randomized, Controlled Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 主要终点
- Need for admissions to NICU secondary to TTN
研究概览
简要总结
Evaluating the effect of early application of Continuous positive airway pressure (CPAP) via Neopuff in cases of transient tachypnea of the newborn(TTN) and its role in decreasing the duration and complication of TTN.
详细描述
The aim of the study is to determine whether positive end expiratory pressure therapy (PEEP) administered early via a T piece based infant resuscitator (Neopuff) would safely reduce the incidence of TTN and the need for neonatal intensive care unit (NICU) admission of near term and term infants with respiratory distress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 2 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Near term infants (36-37 weeks gestational age) and Full term infants (38-41 weeks gestational age).
- •Presence of signs of respiratory distress (Tachypnea, intercostal and subcostal retractions, nasal flaring and grunting) evident shortly after birth.
- •Cesarean section (CS) was defined as elective when surgery was performed before the onset of labor, with all other cases defined as secondary CS.
排除标准
- •Presence of any of the risk factors for neonatal sepsis such as Prolonged Rupture of Membranes for ≥48 hours (PROM), maternal fever, maternal chorioamnionitis or positive maternal GBS colonization.
- •Presence of any other cause of respiratory distress, eg.
- •congenital malformations affecting the cardiorespiratory system ,
- •chromosomal aberrations,
- •depression at birth (Apgar score at 5 minutes of < 7 or umbilical artery pH of < 7.10),
- •fetal hydrops,
- •persistent pulmonary hypertension,
- •and meconium aspiration syndrome.
结局指标
主要结局
Need for admissions to NICU secondary to TTN
时间窗: 24 hours
次要结局
- Levels of plasma brain natriuretic peptide and clinical outcome [Time Frame: 24 hours].(24 hours)
- Duration of tachypnea.(until discharge)
- Duration and type of oxygen therapy.(ntil discharge)
- Antibiotic treatment.(until discharge)
- Incidence of pulmonary air leaks(ntil discharge)
- Length of hospital (NICU) stay(until discharge)
- Death(until discharge)
研究者
Rania Ali El-Farrash
Lecturer of Pediatrics
Ain Shams University
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