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

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

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

Study Overview

• Status: Completed
• Conditions: Preterm Neonates
• Intervention / Treatment: Procedure: Gradual weaning from Nasal CPAP in preterm neonates

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11219
      • Maimonides Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gradual wean from Nasal CPAP; 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; 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.; Other Names: Nasal CPAP; Weaning; Preterm neonates
No Intervention: Sudden wean from Nasal CPAP; Usual practice to wean the preterm neonates from nasal CPAP

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maimonides Medical Center
• Investigators: Principal Investigator: Shantanu Rastogi, MD, Maimonides Medical Center; Principal Investigator: Alok Bhutada, MD, Maimonides Medical Center

Publications and helpful links

Helpful Links

• pubmed abstract

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: September 27, 2010
• First Submitted That Met QC Criteria: October 5, 2010
• First Posted (Estimate): October 6, 2010

Study Record Updates

• Last Update Posted (Estimate): October 24, 2012
• Last Update Submitted That Met QC Criteria: October 22, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Weaning; Neonatal; Nasal CPAP
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: Maimonides Project 07/10/VA5