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

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

Detailed Description
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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.

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

Conditions
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Preterm Neonates

Intervention / Treatment
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* Procedure: Gradual weaning from Nasal CPAP in preterm neonates


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gradual wean from Nasal CPAP<br>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. | Procedure: Gradual weaning from Nasal CPAP in preterm neonates<br>* 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.<br>* Other names: Preterm neonates;|
| No Intervention: Sudden wean from Nasal CPAP<br>Usual practice to wean the preterm neonates from nasal CPAP | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weights when the neonates could come off oxygen | Weights when the neonates could come off oxygen | During the initial NICU stay | 
| length of stay in the hospital | length of stay in the hospital | During the initial NICU stay | 
| Post-menstrual age when preterm neonates could come off oxygen | Post-menstrual age when preterm neonates could come off oxygen | During the initial NICU stay | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonatal, Nasal CPAP, Randomized controlled trial, Weaning