Trial of Weaning of Nasal Continuous Positive Airway Pressure (CPAP)

Not Applicable

Completed

• Conditions: Preterm Neonates
• Interventions: Procedure: Gradual weaning from Nasal CPAP in preterm neonates

• Registration Number: NCT01215591
• Lead Sponsor: Maimonides Medical Center

Brief Summary

To compare the 2 methods of weaning of nasal CPAP in premature babies born at 32 weeks or less

Detailed Description

Objective: To study the weight and the post menstrual age (PMA) at the time of nasal CPAP (NCPAP) wean utilizing the method of sudden wean as compared to gradual wean. . Methods: A prospective randomized trial was conducted comparing sudden weaning with gradual weaning from NCPAP in neonates with gestational age (GA) \<32 weeks. The patients were randomized to one of the two methods of weaning from NCPAP and their success was compared.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2010-09-27
• Study First Submitted QC: 2010-10-05
• Study First Posted: 2010-10-06
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-22
• Last Update Posted: 2012-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

All babies born with GA <32 weeks admitted to the neonatal intensive care units at the Maimonides Infant and Children's Hospital, between 1st January 2008 and 31st March 2009 and required to be on NCPAP for longer than 48 hours.-

Exclusion Criteria

Those with severe congenital anomalies and chromosomal defects including congenital heart disease and neurological malformations, chest wall or airway abnormalities and lung hypoplasia, were excluded from the cohort

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gradual wean from Nasal CPAP	Gradual weaning from Nasal CPAP in preterm neonates	Nasal CPAP for gradual wean group it was cycled off for 3 hours alternating with 3 hours on for first 48 hours, if successful the cycle was extended to 6 hours off and 3 hours on for the next 48 hours. If the baby tolerated this regime the prongs were removed and CPAP was kept off.

Primary Outcome Measures

Name	Time	Method
Weight when preterm neonates could come off nasal CPAP	During the initial NICU stay	Weight when preterm neonates could come off nasal CPAP
Post-menstrual age when preterm neonates could come off nasal CPAP	During the initial NICU stay	Post-menstrual age when preterm neonates could come off nasal CPAP

Secondary Outcome Measures

Name	Time	Method
Weights when the neonates could come off oxygen	During the initial NICU stay	Weights when the neonates could come off oxygen
length of stay in the hospital	During the initial NICU stay	length of stay in the hospital
Post-menstrual age when preterm neonates could come off oxygen	During the initial NICU stay	Post-menstrual age when preterm neonates could come off oxygen

Trial Locations

Locations (1)

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States