Trial of Weaning of Nasal Continuous Positive Airway Pressure (CPAP)
Randomized Controlled Trial of Gradual Versus Sudden Weaning From Nasal CPAP in Preterm Neonates
1 other identifier
interventional
56
1 country
1
Brief Summary
To compare the 2 methods of weaning of nasal CPAP in premature babies born at 32 weeks or less
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2008
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
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 27, 2010
CompletedFirst Posted
Study publicly available on registry
October 6, 2010
CompletedOctober 24, 2012
October 1, 2012
1.2 years
September 27, 2010
October 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Weight when preterm neonates could come off nasal CPAP
Weight when preterm neonates could come off nasal CPAP
During the initial NICU stay
Post-menstrual age when preterm neonates could come off nasal CPAP
Post-menstrual age when preterm neonates could come off nasal CPAP
During the initial NICU stay
Secondary Outcomes (3)
Weights when the neonates could come off oxygen
During the initial NICU stay
length of stay in the hospital
During the initial NICU stay
Post-menstrual age when preterm neonates could come off oxygen
During the initial NICU stay
Study Arms (2)
Gradual wean from Nasal CPAP
ACTIVE COMPARATORNasal CPAP for gradual wean group it was cycled off for 3 hours alternating with 3 hours on for first 48 hours, if successful the cycle was extended to 6 hours off and 3 hours on for the next 48 hours. If the baby tolerated this regime the prongs were removed and CPAP was kept off.
Sudden wean from Nasal CPAP
NO INTERVENTIONUsual practice to wean the preterm neonates from nasal CPAP
Interventions
Nasal CPAP for gradual wean group it was cycled off for 3 hours alternating with 3 hours on for first 48 hours, if successful the cycle was extended to 6 hours off and 3 hours on for the next 48 hours. If the baby tolerated this regime the prongs were removed and CPAP was kept off.
Eligibility Criteria
You may qualify if:
- All babies born with GA \<32 weeks admitted to the neonatal intensive care units at the Maimonides Infant and Children's Hospital, between 1st January 2008 and 31st March 2009 and required to be on NCPAP for longer than 48 hours.-
You may not qualify if:
- Those with severe congenital anomalies and chromosomal defects including congenital heart disease and neurological malformations, chest wall or airway abnormalities and lung hypoplasia, were excluded from the cohort
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maimonides Medical Center
Brooklyn, New York, 11219, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shantanu Rastogi, MD
Maimonides Medical Center
- PRINCIPAL INVESTIGATOR
Alok Bhutada, 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
- PRINCIPAL INVESTIGATOR
- PI Title
- Neonatologist
Study Record Dates
First Submitted
September 27, 2010
First Posted
October 6, 2010
Study Start
January 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
October 24, 2012
Record last verified: 2012-10