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

Transient Tachypnea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01082900
• Other study ID #: 5720108
• Status: Completed
• Phase: N/A
• First received: March 8, 2010
• Last updated: October 5, 2015
• Start date: November 2009
• Est. completion date: April 2013

Study information

• Verified date: October 2015
• Source: New York Hospital Queens
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: April 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 30 Minutes

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tachypnea
• Transient Tachypnea
• Transient Tachypnea of the Newborn

Intervention

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

Locations

Country	Name	City	State
United States	New York Hospital Queens	Flushing	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Hospital Queens

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of incidence of TTN		24 hours	Yes
Primary	Need for admissions to NICU secondary to TTN		24 hours	Yes
Secondary	levels of plasma brain natriuretic peptide compared	Duration of tachypnea; Duration of oxygen therapy; Length of hospital (NICU) stay	24 hours	Yes