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

New York Hospital Queens

Status: Completed

Conditions: Transient Tachypnea

Treatments: Other: Prophylactic CPAP Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT01082900

5720108

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: All

Ages: 2 to 30 minutes old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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138 participants in 2 patient groups

Prophylactic CPAP intervention

Experimental group

Description:

Babies will receive prophylactic administration of CPAP (5 cm of H2O) in the DR via T piece (Neopuff)

Treatment:

Other: Prophylactic CPAP Administration

No Intervention

Active Comparator group

Description:

Provision of standard care in the Delivery Room

Treatment:

Other: Prophylactic CPAP Administration