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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
pinchi srinivasan, New York Hospital Queens
ClinicalTrials.gov Identifier:
NCT01082900
First received: March 8, 2010
Last updated: October 5, 2015
Last verified: October 2015
  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
Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
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:


Further study details as provided by pinchi srinivasan, New York Hospital Queens:

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

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


Enrollment: 138
Study Start Date: November 2009
Study Completion Date: April 2013
Primary Completion Date: January 2013 (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   (Child)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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: October 5, 2015

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

Additional relevant MeSH terms:
Tachypnea
Transient Tachypnea of the Newborn
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiratory Distress Syndrome, Newborn
Lung Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on August 18, 2017