Respiratory Transition Without Continuous Positive Airway Pressure in Term Infants With Mild Respiratory Distress: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Need for CPAP use at 25 minutes of life
研究概览
简要总结
The primary aim of this research project is to determine if term neonates (37:0 to 41:6 weeks' gestational age) with mild respiratory distress can safely transition without continuous positive airway pressure (CPAP). The secondary aim is to determine the incidence of pneumothorax (PTX) for all term neonates assessed to have mild respiratory distress in the delivery room (DR).
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
- 37 Weeks 至 41 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Full term infants (37 weeks + 0days to 41 weeks +6days gestational age)
- •Born via scheduled c-sections without labor
- •Who develop mild respiratory distress, defined as nasal flaring or, intermittent grunting, and/or mild retractions and/or +/- mild tachypnea ( respiratory rate 61-90).
排除标准
- •Moderate to severe respiratory distress (continuous grunting, or moderate retractions or respiratory rate greater than 90 breaths per minute),
- •need for positive pressure ventilation (PPV) or advanced resuscitation in the first 5 minutes of life,
- •meconium stained amniotic fluid,
- •major congenital anomalies or chromosomal abnormalities.
研究组 & 干预措施
Standard of care
Continuous positive airway pressure (CPAP) is administered for mild respiratory distress
干预措施: CPAP (Other)
Watchful waiting
Neonates with mild respiratory distress are observed for 20 minutes, and CPAP is administered at 25 minutes of life if respiratory distress continues or earlier if moderate to severe respiratory distress occurs
干预措施: Transition without Continuous Positive Airway Pressure (CPAP) (Other)
结局指标
主要结局
Need for CPAP use at 25 minutes of life
时间窗: At 25 minutes post birth (after 20 minutes of observation)
Babies with mild respiratory distress will be observed for 20 minutes (randomized at 5 minutes of life) using a pulse oximeter (per institutional post-resuscitation care guidelines) and under the study team's direct observation. The active cohort will not receive CPAP unless respiratory distress worsens.
次要结局
- Prevalence of pneumothorax in neonates(Within 6 hours of life)
- NICU (Neonatal Intensive Care Unit) admission during hospital stay(Hospital day (from birth to discharge))