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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01082900

Enrollment

138

Registered

2010-03-09

Start date

2009-11-30

Completion date

2013-04-30

Last updated

2015-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transient Tachypnea

Keywords

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

Brief 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.

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

ALL

Age

2 Minutes to 30 Minutes

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

* 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.

Design outcomes

Primary

Measure	Time frame
Measure of incidence of TTN	24 hours
Need for admissions to NICU secondary to TTN	24 hours

Secondary

Measure	Time frame	Description
levels of plasma brain natriuretic peptide compared	24 hours	* Duration of tachypnea * Duration of oxygen therapy * Length of hospital (NICU) stay

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026