Back to resultsComparing Weaning of Nasal Continuous Positive Airway Pressure (CPAP) From Preterm Infants
Primary Purpose
Respiratory Distress Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gradual pressure wean
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Distress Syndrome focused on measuring weaning, NCPAP, Preterm, sudden wean, gradual pressure off wean
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
Sites / Locations
- Maimonides medcial center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Sudden wean
Gradual pressure wean
Arm Description
When ready Nasal Continuous Positive Airway Pressure (NCPAP) will be removed from the neonate
NCPAP will be removed by gradually decreasing pressure over 24 hours once the weaning is decided
Outcomes
Primary Outcome Measures
Success of weaning on first trial off NCPAP
Secondary Outcome Measures
Weight and corrected GA when come off oxygen
Weight and corrected gestational age (GA) when neonates could come off NCPAP
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02126501
Brief Title
Comparing Weaning of Nasal Continuous Positive Airway Pressure (CPAP) From Preterm Infants
Official Title
Randomized Control Trial of Weaning NCPAP From Preterm Infants: Sudden Wean Versus Weaning by Gradually Decreasing Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maimonides Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
Keywords
weaning, NCPAP, Preterm, sudden wean, gradual pressure off wean
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sudden wean
Arm Type
No Intervention
Arm Description
When ready Nasal Continuous Positive Airway Pressure (NCPAP) will be removed from the neonate
Arm Title
Gradual pressure wean
Arm Type
Active Comparator
Arm Description
NCPAP will be removed by gradually decreasing pressure over 24 hours once the weaning is decided
Intervention Type
Other
Intervention Name(s)
Gradual pressure wean
Intervention Description
NCPAP will be removed by gradually decreasing pressure over 24 hours once the weaning is decided
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Weight and corrected GA when come off oxygen
Time Frame
when off supplemental oxygen expected average of 2 weeks
Title
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
Other Pre-specified Outcome Measures:
Title
length of stay in the neonatal intensive care unit
Time Frame
when ready to be discharged, expected average of 6-8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
26 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shantanu Rastogi, MD
Organizational Affiliation
Maimonides Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maimonides medcial center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28230835
Citation
Amatya S, Macomber M, Bhutada A, Rastogi D, Rastogi S. Sudden versus gradual pressure wean from Nasal CPAP in preterm infants: a randomized controlled trial. J Perinatol. 2017 Jun;37(6):662-667. doi: 10.1038/jp.2017.10. Epub 2017 Feb 23.
Results Reference
derived
Learn more about this trial
Comparing Weaning of Nasal Continuous Positive Airway Pressure (CPAP) From Preterm Infants
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