Prophylactic CPAP/PEEP in Delivery Room (DR) Resuscitation, Effects on Natriuretic Peptide in the Prevention of Transient Tachypnea of Newborn (TTN): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Need for admissions to NICU secondary to TTN
研究概览
简要总结
Transient Tachypnea of the Newborn (TTN) is a disorder of delayed clearance of lung liquid and a common cause of admission of full term infants and late pre term infants (34 to 36 weeks) to Neonatal Intensive Care Units (NICU). Both late preterm gestational age at delivery, and mode of delivery are considered risk factors for TTN. The investigators hypothesize that CPAP administered prophylactically in the Delivery Room via a T piece based infant resuscitator Neopuff, to neonates at increased risk for TTN, would decrease the incidence of TTN and thus decrease the need for hospitalization in the NICU. This is a pilot study to evaluate the prophylactic administration of CPAP in the Delivery Room towards prevention of TTN and it's effects on natriuretic peptides.The study will be conducted as a randomized control trial after obtaining informed consents from the parents of eligible infants. Infants will be randomized to receive either experimental treatment (prophylactic CPAP) or standardized care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 2 Minutes 至 30 Minutes(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Babies born to mothers via elective CS: elective CS defined as planned CS in the absence of Labor.
- •Late preterm infants (34 1/7 to 36 6/7 weeks gestational age)
排除标准
- •Presence of any of the risk factors for neonatal sepsis such as Prolonged Rupture of Membranes for ≥18 hours (PROM), maternal fever, maternal chorioamnionitis or positive maternal GBS colonization
- •Need for use of PPV for perinatal depression or other indications
- •Presence of any of the following
- •congenital malformations (diagnosed prenatally)
- •chromosomal anomalies (diagnosed prenatally)
- •congenital heart disease diagnosed by fetal echocardiography.
结局指标
主要结局
Need for admissions to NICU secondary to TTN
时间窗: 24 hours
Measure of incidence of TTN
时间窗: 24 hours
次要结局
- levels of plasma brain natriuretic peptide compared(24 hours)
研究者
pinchi srinivasan
MD
New York Hospital Queens
