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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shantanu Rastogi, Maimonides Medical Center
ClinicalTrials.gov Identifier:
NCT01215591
First received: September 27, 2010
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention
Preterm Neonates
Procedure: Gradual weaning from Nasal CPAP in preterm neonates

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Gradual Versus Sudden Weaning From Nasal CPAP in Preterm Neonates

Further study details as provided by Maimonides Medical Center:

Primary Outcome Measures:
  • Weight when preterm neonates could come off nasal CPAP [ Time Frame: During the initial NICU stay ] [ Designated as safety issue: No ]
    Weight when preterm neonates could come off nasal CPAP

  • Post-menstrual age when preterm neonates could come off nasal CPAP [ Time Frame: During the initial NICU stay ] [ Designated as safety issue: No ]
    Post-menstrual age when preterm neonates could come off nasal CPAP


Secondary Outcome Measures:
  • Weights when the neonates could come off oxygen [ Time Frame: During the initial NICU stay ] [ Designated as safety issue: No ]
    Weights when the neonates could come off oxygen

  • length of stay in the hospital [ Time Frame: During the initial NICU stay ] [ Designated as safety issue: No ]
    length of stay in the hospital

  • Post-menstrual age when preterm neonates could come off oxygen [ Time Frame: During the initial NICU stay ] [ Designated as safety issue: No ]
    Post-menstrual age when preterm neonates could come off oxygen


Enrollment: 56
Study Start Date: January 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   24 Weeks to 32 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01215591

Locations
United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Maimonides Medical Center
Investigators
Principal Investigator: Shantanu Rastogi, MD Maimonides Medical Center
Principal Investigator: Alok Bhutada, MD Maimonides Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Shantanu Rastogi, Neonatologist, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT01215591     History of Changes
Other Study ID Numbers: Maimonides Project 07/10/VA5
Study First Received: September 27, 2010
Last Updated: October 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Maimonides Medical Center:
Neonatal
Nasal CPAP
Randomized controlled trial
Weaning

ClinicalTrials.gov processed this record on September 30, 2014