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

September 27, 2010
October 22, 2012
January 2008
March 2009   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01215591 on ClinicalTrials.gov Archive Site
  • 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
  • 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 ]
    lenght 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
Not Provided
Not Provided
 
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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Preterm Neonates
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
  • 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.
    Intervention: Procedure: Gradual weaning from Nasal CPAP in preterm neonates
  • No Intervention: Sudden wean from Nasal CPAP
    Usual practice to wean the preterm neonates from nasal CPAP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
March 2009
March 2009   (final data collection date for primary outcome measure)

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

Both
24 Weeks to 32 Weeks
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01215591
Maimonides Project 07/10/VA5
No
Shantanu Rastogi, Maimonides Medical Center
Maimonides Medical Center
Not Provided
Principal Investigator: Shantanu Rastogi, MD Maimonides Medical Center
Principal Investigator: Alok Bhutada, MD Maimonides Medical Center
Maimonides Medical Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP