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

Not Applicable

Completed

• Conditions: Transient Tachypnea
• Interventions: Other: Prophylactic CPAP Administration

• Registration Number: NCT01082900
• Lead Sponsor: New York Hospital Queens

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-03-08
• Study First Submitted QC: 2010-03-08
• Study First Posted: 2010-03-09
• Primary Completion: 2013-01
• Study Completion: 2013-04
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
No Intervention	Prophylactic CPAP Administration	Provision of standard care in the Delivery Room
Prophylactic CPAP intervention	Prophylactic CPAP Administration	Babies will receive prophylactic administration of CPAP (5 cm of H2O) in the DR via T piece (Neopuff)

Primary Outcome Measures

Name	Time	Method
Need for admissions to NICU secondary to TTN	24 hours
Measure of incidence of TTN	24 hours

Secondary Outcome Measures

Name	Time	Method
levels of plasma brain natriuretic peptide compared	24 hours	* Duration of tachypnea; * Duration of oxygen therapy; * Length of hospital (NICU) stay

Trial Locations

Locations (1)

New York Hospital Queens; 🇺🇸 Flushing, New York, United States