Prophylactic Continuous Positive Airway Pressure (CPAP) in Delivery Room, in the Prevention of Transient Tachypnea of Newborn (TTN): A Randomized Controlled Trial

Completed · Not applicable

Conditions studied: Transient Tachypnea

In brief

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.

Key facts

Study ID

NCT01082900

Run by

New York Hospital Queens

People needed

138

Starts

2009-11-01

Expected to finish

2013-04-01

Last updated by the study team

2015-10-06

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• New York Hospital Queens — Flushing, New York, United States

Full record on ClinicalTrials.gov

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