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

NCT01082900 | Completed DMC

• 1 other identifier: 5720108
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Transient Tachypnea

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Measure of incidence of TTN

  24 hours

• Need for admissions to NICU secondary to TTN

  24 hours

Secondary Outcomes (1)

• levels of plasma brain natriuretic peptide compared

  24 hours

Study Arms (2)

Prophylactic CPAP intervention

EXPERIMENTAL

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

Other: Prophylactic CPAP Administration

No Intervention

ACTIVE COMPARATOR

Provision of standard care in the Delivery Room

Other: Prophylactic CPAP Administration

Interventions

Prophylactic CPAP Administration OTHER

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

No Intervention; Prophylactic CPAP intervention

Eligibility Criteria

• Age: 2 Minutes - 30 Minutes
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York Hospital Queens: lead

Study Sites (1)

New York Hospital Queens

Flushing, New York, 11355, United States

Location

MeSH Terms

Conditions

Transient Tachypnea of the Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Tachypnea; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pinchi Srinivasan, MD

  New York Hospital Queens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 9, 2010
• Study Start: November 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2013
• Last Updated: October 6, 2015

Record last verified: 2015-10

Locations

US (1)