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Trial of Weaning of Nasal Continuous Positive Airway Pressure (CPAP)

Randomized Controlled Trial of Gradual Versus Sudden Weaning From Nasal CPAP in Preterm Neonates

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01215591
Enrollment
56
Registered
2010-10-06
Start date
2008-01-31
Completion date
2009-03-31
Last updated
2012-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Neonates

Keywords

Neonatal, Nasal CPAP, Randomized controlled trial, Weaning

Brief summary

To compare the 2 methods of weaning of nasal CPAP in premature babies born at 32 weeks or less

Detailed description

Objective: To study the weight and the post menstrual age (PMA) at the time of nasal CPAP (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 (GA) \<32 weeks. The patients were randomized to one of the two methods of weaning from NCPAP and their success was compared.

Interventions

PROCEDUREGradual weaning from Nasal CPAP in preterm neonates

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.

Sponsors

Maimonides Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
24 Weeks to 32 Weeks
Healthy volunteers
No

Inclusion criteria

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.-

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Weight when preterm neonates could come off nasal CPAPDuring the initial NICU stayWeight when preterm neonates could come off nasal CPAP
Post-menstrual age when preterm neonates could come off nasal CPAPDuring the initial NICU stayPost-menstrual age when preterm neonates could come off nasal CPAP

Secondary

MeasureTime frameDescription
Weights when the neonates could come off oxygenDuring the initial NICU stayWeights when the neonates could come off oxygen
length of stay in the hospitalDuring the initial NICU staylength of stay in the hospital
Post-menstrual age when preterm neonates could come off oxygenDuring the initial NICU stayPost-menstrual age when preterm neonates could come off oxygen

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026