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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by New York Hospital Queens.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
New York Hospital Queens
ClinicalTrials.gov Identifier:
NCT01082900
First received: March 8, 2010
Last updated: July 21, 2011
Last verified: February 2010
History of Changes
  Purpose

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.


Condition Intervention
Transient Tachypnea
 Other: Prophylactic CPAP Administration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by New York Hospital Queens:

Primary Outcome Measures:
  • Measure of incidence of TTN [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Need for admissions to NICU secondary to TTN [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • levels of plasma brain natriuretic peptide compared [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    • Duration of tachypnea
    • Duration of oxygen therapy
    • Length of hospital (NICU) stay


Estimated Enrollment: 400
Study Start Date: November 2009
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 30 Minutes
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082900

Contacts
Contact: Pinchi Srinivasan, MD 7186701184 pns9001@nyp.org

Locations
United States, New York
New York Hospital Queens Recruiting
Flushing, New York, United States, 11355
Contact: Pinchi Srinivasan, MD            
Principal Investigator: Pinchi Srinivasan, MD            
Sponsors and Collaborators
New York Hospital Queens
Investigators
Principal Investigator: Pinchi Srinivasan, MD New York Hospital Queens
  More Information

No publications provided

Responsible Party: Pinchi Srinivasan, MD, New York hospital Queens
ClinicalTrials.gov Identifier: NCT01082900     History of Changes
Other Study ID Numbers: 5720108
Study First Received: March 8, 2010
Last Updated: July 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by New York Hospital Queens:
Transient Tachypnea of the Newborn
Elective Cesarean section
Late preterm
CPAP
Delivery Room

ClinicalTrials.gov processed this record on May 19, 2013