Randomized Control Trial of Weaning NCPAP From Preterm Infants: Sudden Wean Versus Weaning by Gradually Decreasing Pressure

Maimonides Medical Center1 site in 1 country70 target enrollmentDecember 2013

ConditionsRespiratory Distress Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Respiratory Distress Syndrome
Sponsor: Maimonides Medical Center
Enrollment: 70
Locations: 1
Primary Endpoint: Success of weaning on first trial off NCPAP
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To compare the 2 methods of weaning of nasal continuous positive airway pressure (CPAP) in premature babies born between 26 and 32 weeks

Detailed Description

To study the weight and the post menstrual age (PMA) at the time of 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 between 26 and 32 weeks. The patients were randomized to one of the two methods of weaning from NCPAP and their success was compared

Registry

clinicaltrials.gov

Start Date

December 2013

End Date

December 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Maimonides Medical Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All neonates born 26 to 32 weeks of gestational age

Exclusion Criteria

•Those with severe congenital anomalies and chromosomal defects including congenital heart disease, neurological malformations, chest and airway abnormalities and lung hypoplasia

Outcomes

Primary Outcomes

Success of weaning on first trial off NCPAP

Time Frame: Completion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks

Secondary Outcomes

Weight and corrected GA when come off oxygen(when off supplemental oxygen expected average of 2 weeks)
Weight and corrected gestational age (GA) when neonates could come off NCPAP(Completion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks)