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临床试验/NCT01082900
NCT01082900已完成不适用

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

New York Hospital Queens2 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2009年11月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

pinchi srinivasan

MD

New York Hospital Queens

研究点 (2)

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