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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02126501
Enrollment
70
Registered
2014-04-30
Start date
2013-12-31
Completion date
2015-12-31
Last updated
2016-06-08

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

Conditions

Respiratory Distress Syndrome

Keywords

weaning, NCPAP, Preterm, sudden wean, gradual pressure off wean

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

Interventions

OTHERGradual pressure wean

NCPAP will be removed by gradually decreasing pressure over 24 hours once the weaning is decided

Sponsors

Maimonides Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frame
Success of weaning on first trial off NCPAPCompletion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks

Secondary

MeasureTime frame
Weight and corrected GA when come off oxygenwhen off supplemental oxygen expected average of 2 weeks
Weight and corrected gestational age (GA) when neonates could come off NCPAPCompletion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks

Other

MeasureTime frame
length of stay in the neonatal intensive care unitwhen ready to be discharged, expected average of 6-8 weeks

Countries

United States

Outcome results

None listed

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