Respiratory Distress Syndrome Clinical Trial
Official title:
Randomized Control Trial of Weaning NCPAP From Preterm Infants: Sudden Wean Versus Weaning by Gradually Decreasing Pressure
Verified date | June 2016 |
Source | Maimonides Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
To compare the 2 methods of weaning of nasal continuous positive airway pressure (CPAP) in premature babies born between 26 and 32 weeks
Status | Completed |
Enrollment | 70 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 26 Weeks to 32 Weeks |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Maimonides medcial center | Brooklyn | New York |
Lead Sponsor | Collaborator |
---|---|
Maimonides Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | length of stay in the neonatal intensive care unit | when ready to be discharged, expected average of 6-8 weeks | No | |
Primary | Success of weaning on first trial off NCPAP | Completion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks | No | |
Secondary | Weight and corrected GA when come off oxygen | when off supplemental oxygen expected average of 2 weeks | No | |
Secondary | 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 | No |
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