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CompletedNCT01082900Updated Oct 6, 2015

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

An interventional study of Prophylactic CPAP Administration in Transient Tachypnea, sponsored by New York Hospital Queens. Completed at 1 site in United States. Open to participants aged 2 Minutes to 30 Minutes, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-06.

Sponsored by New York Hospital Queens · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
138
Allocation
Randomized
Ages
2 Minutes to 30 Minutes
Sex
All
01

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.

02

Conditions studied

  • Transient Tachypnea

Keywords

  • Transient Tachypnea of the Newborn
  • Elective Cesarean section
  • Late preterm
  • CPAP
  • Delivery Room
03

In context

Tachypnea

39 studies on the registry are indexed under Tachypnea; 4 are open to participants now.

This study's enrollment of 138 is above the median of 100 across 30 interventional studies indexed under Tachypnea.

Browse Tachypnea studies →

Lead sponsor

New York Hospital Queens is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Minutes to 30 Minutes
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
Single (Care provider)
Enrollment
138 participants (actual)

Study arms

  • 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

  • Active comparator
    No Intervention

    Provision of standard care in the Delivery Room

    Other: Prophylactic CPAP Administration

Interventions

  • OtherProphylactic 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

06

What researchers measure

Primary outcomes

  1. Measure of incidence of TTN

    Time frame: 24 hours

  2. Need for admissions to NICU secondary to TTN

    Time frame: 24 hours

Secondary outcomes

  1. levels of plasma brain natriuretic peptide compared

    * Duration of tachypnea * Duration of oxygen therapy * Length of hospital (NICU) stay

    Time frame: 24 hours

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Study locations

1 site
  • New York Hospital Queens
    Flushing, New York 11355, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01082900
Lead sponsor
New York Hospital Queens
Responsible party
pinchi srinivasan (MD, New York Hospital Queens) — Principal investigator
First posted
Mar 9, 2010
Start date
Nov 2009
Primary completion
Jan 2013
Completion
Apr 2013
Last update
Oct 6, 2015

Study contacts

Pinchi Srinivasan, MD
principal investigator · New York Hospital Queens

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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