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

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ClinicalTrials.gov Identifier: NCT01215591
Recruitment Status : Completed
First Posted : October 6, 2010
Last Update Posted : October 24, 2012
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Preterm Neonates 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Gradual Versus Sudden Weaning From Nasal CPAP in Preterm Neonates
Study Start Date : January 2008
Primary Completion Date : March 2009
Study Completion Date : March 2009
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Weight when preterm neonates could come off nasal CPAP [ Time Frame: During the initial NICU stay ]
    Weight when preterm neonates could come off nasal CPAP

  2. Post-menstrual age when preterm neonates could come off nasal CPAP [ Time Frame: During the initial NICU stay ]
    Post-menstrual age when preterm neonates could come off nasal CPAP


Secondary Outcome Measures :
  1. Weights when the neonates could come off oxygen [ Time Frame: During the initial NICU stay ]
    Weights when the neonates could come off oxygen

  2. length of stay in the hospital [ Time Frame: During the initial NICU stay ]
    length of stay in the hospital

  3. Post-menstrual age when preterm neonates could come off oxygen [ Time Frame: During the initial NICU stay ]
    Post-menstrual age when preterm neonates could come off oxygen


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   24 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Shantanu Rastogi, Neonatologist, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT01215591     History of Changes
Other Study ID Numbers: Maimonides Project 07/10/VA5
First Posted: October 6, 2010    Key Record Dates
Last Update Posted: October 24, 2012
Last Verified: October 2012

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

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications