- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02126501
Comparing Weaning of Nasal Continuous Positive Airway Pressure (CPAP) From Preterm Infants
Randomized Control Trial of Weaning NCPAP From Preterm Infants: Sudden Wean Versus Weaning by Gradually Decreasing Pressure
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Brooklyn, New York, United States, 11219
- Maimonides medcial center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Sudden wean
When ready Nasal Continuous Positive Airway Pressure (NCPAP) will be removed from the neonate
|
|
Active Comparator: Gradual pressure wean
NCPAP will be removed by gradually decreasing pressure over 24 hours once the weaning is decided
|
NCPAP will be removed by gradually decreasing pressure over 24 hours once the weaning is decided
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Success of weaning on first trial off NCPAP
Time Frame: Completion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks
|
Completion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Weight and corrected GA when come off oxygen
Time Frame: when off supplemental oxygen expected average of 2 weeks
|
when off supplemental oxygen expected average of 2 weeks
|
Weight and corrected gestational age (GA) when neonates could come off NCPAP
Time Frame: Completion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks
|
Completion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
length of stay in the neonatal intensive care unit
Time Frame: when ready to be discharged, expected average of 6-8 weeks
|
when ready to be discharged, expected average of 6-8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shantanu Rastogi, MD, Maimonides Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMC 13/01/VA03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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