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NCT02126501 Clinical Trial

Comparing Weaning of Nasal Continuous Positive Airway Pressure (CPAP) From Preterm Infants

Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02126501
Other study ID # MMC 13/01/VA03
Secondary ID
Status Completed
Phase N/A
First received March 17, 2014
Last updated June 6, 2016
Start date December 2013
Est. completion date December 2015

Study information
Verified date June 2016
Source Maimonides Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 26 Weeks to 32 Weeks
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Gradual pressure wean
NCPAP will be removed by gradually decreasing pressure over 24 hours once the weaning is decided

Locations
Country Name City State
United States Maimonides medcial center Brooklyn New York

Sponsors (1)
Lead Sponsor Collaborator
Maimonides Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other length of stay in the neonatal intensive care unit when ready to be discharged, expected average of 6-8 weeks No
Primary Success of weaning on first trial off NCPAP Completion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks No
Secondary Weight and corrected GA when come off oxygen when off supplemental oxygen expected average of 2 weeks No
Secondary 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 No
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