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

NCT01082900 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2015-10-06

No results posted yet for this study

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.

Conditions

  • Transient Tachypnea

Interventions

OTHER

Prophylactic CPAP Administration

EXPERIMENTAL GROUP: Babies will receive prophylactic administration of CPAP (5 cm of H2O) in the Delivery Room via T piece (Neopuff) CONTROL GROUP: Provision of standard care in the Delivery Room

Sponsors & Collaborators

  • New York Hospital Queens

    lead OTHER

Principal Investigators

  • Pinchi Srinivasan, MD · New York Hospital Queens

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Minutes
Max Age
30 Minutes
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2013-01-31
Completion
2013-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01082900 on ClinicalTrials.gov