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

March 8, 2010
July 21, 2011
November 2009
December 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01082900 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Prophylactic Continuous Positive Airway Pressure (CPAP) in Delivery Room, in the Prevention of Transient Tachypnea of Newborn (TTN): A Randomized Controlled Trial
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
Transient Tachypnea
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

  • Experimental: Prophylactic CPAP intervention
    Babies will receive prophylactic administration of CPAP (5 cm of H2O) in the DR via T piece (Neopuff)
    Intervention: Other: Prophylactic CPAP Administration
  • Active Comparator: No Intervention
    Provision of standard care in the Delivery Room
    Intervention: Other: Prophylactic CPAP Administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
February 2012
December 2011   (final data collection date for primary outcome measure)

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.
Both
up to 30 Minutes
Yes
Contact: Pinchi Srinivasan, MD 7186701184 pns9001@nyp.org
United States
 
NCT01082900
5720108
Yes
Pinchi Srinivasan, MD, New York hospital Queens
New York Hospital Queens
Not Provided
Principal Investigator: Pinchi Srinivasan, MD New York Hospital Queens
New York Hospital Queens
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP