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

October 5, 2015 updated by: pinchi srinivasan, New York Hospital Queens

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Flushing, New York, United States, 11355
        • New York Hospital Queens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 minutes to 30 minutes (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Prophylactic CPAP intervention
Babies will receive prophylactic administration of CPAP (5 cm of H2O) in the DR via T piece (Neopuff)
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
ACTIVE_COMPARATOR: No Intervention
Provision of standard care in the Delivery Room
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Need for admissions to NICU secondary to TTN
Time Frame: 24 hours
24 hours
Measure of incidence of TTN
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
levels of plasma brain natriuretic peptide compared
Time Frame: 24 hours
  • Duration of tachypnea
  • Duration of oxygen therapy
  • Length of hospital (NICU) stay
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York Hospital Queens

Investigators

  • Principal Investigator: Pinchi Srinivasan, MD, New York Hospital Queens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

March 8, 2010

First Submitted That Met QC Criteria

March 8, 2010

First Posted (ESTIMATE)

March 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 6, 2015

Last Update Submitted That Met QC Criteria

October 5, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5720108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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