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
1 other identifier
interventional
70
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 17, 2014
CompletedFirst Posted
Study publicly available on registry
April 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJune 8, 2016
June 1, 2016
2 years
March 17, 2014
June 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Success of weaning on first trial off NCPAP
Completion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks
Secondary Outcomes (2)
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
Other Outcomes (1)
length of stay in the neonatal intensive care unit
when ready to be discharged, expected average of 6-8 weeks
Study Arms (2)
Sudden wean
NO INTERVENTIONWhen ready Nasal Continuous Positive Airway Pressure (NCPAP) will be removed from the neonate
Gradual pressure wean
ACTIVE COMPARATORNCPAP will be removed by gradually decreasing pressure over 24 hours once the weaning is decided
Interventions
NCPAP will be removed by gradually decreasing pressure over 24 hours once the weaning is decided
Eligibility Criteria
You may qualify if:
- All neonates born 26 to 32 weeks of gestational age
You may not qualify if:
- Those with severe congenital anomalies and chromosomal defects including congenital heart disease, neurological malformations, chest and airway abnormalities and lung hypoplasia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maimonides medcial center
Brooklyn, New York, 11219, United States
Related Publications (1)
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.
PMID: 28230835DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shantanu Rastogi, MD
Maimonides Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2014
First Posted
April 30, 2014
Study Start
December 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
June 8, 2016
Record last verified: 2016-06