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

Primary Purpose

Preterm Neonates

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gradual weaning from Nasal CPAP in preterm neonates
Sponsored by
Maimonides Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Neonates focused on measuring Neonatal, Nasal CPAP, Randomized controlled trial, Weaning

Eligibility Criteria

24 Weeks - 32 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maimonides Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Gradual wean from Nasal CPAP

Sudden wean from Nasal CPAP

Arm Description

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.

Usual practice to wean the preterm neonates from nasal CPAP

Outcomes

Primary Outcome Measures

Weight when preterm neonates could come off nasal CPAP
Weight when preterm neonates could come off nasal CPAP
Post-menstrual age when preterm neonates could come off nasal CPAP
Post-menstrual age when preterm neonates could come off nasal CPAP

Secondary Outcome Measures

Weights when the neonates could come off oxygen
Weights when the neonates could come off oxygen
length of stay in the hospital
length of stay in the hospital
Post-menstrual age when preterm neonates could come off oxygen
Post-menstrual age when preterm neonates could come off oxygen

Full Information

First Posted
September 27, 2010
Last Updated
October 22, 2012
Sponsor
Maimonides Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01215591
Brief Title
Trial of Weaning of Nasal Continuous Positive Airway Pressure (CPAP)
Official Title
Randomized Controlled Trial of Gradual Versus Sudden Weaning From Nasal CPAP in Preterm Neonates
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maimonides Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Neonates
Keywords
Neonatal, Nasal CPAP, Randomized controlled trial, Weaning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gradual wean from Nasal CPAP
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sudden wean from Nasal CPAP
Arm Type
No Intervention
Arm Description
Usual practice to wean the preterm neonates from nasal CPAP
Intervention Type
Procedure
Intervention Name(s)
Gradual weaning from Nasal CPAP in preterm neonates
Other Intervention Name(s)
Nasal CPAP, Weaning, Preterm neonates
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight when preterm neonates could come off nasal CPAP
Description
Weight when preterm neonates could come off nasal CPAP
Time Frame
During the initial NICU stay
Title
Post-menstrual age when preterm neonates could come off nasal CPAP
Description
Post-menstrual age when preterm neonates could come off nasal CPAP
Time Frame
During the initial NICU stay
Secondary Outcome Measure Information:
Title
Weights when the neonates could come off oxygen
Description
Weights when the neonates could come off oxygen
Time Frame
During the initial NICU stay
Title
length of stay in the hospital
Description
length of stay in the hospital
Time Frame
During the initial NICU stay
Title
Post-menstrual age when preterm neonates could come off oxygen
Description
Post-menstrual age when preterm neonates could come off oxygen
Time Frame
During the initial NICU stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shantanu Rastogi, MD
Organizational Affiliation
Maimonides Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alok Bhutada, MD
Organizational Affiliation
Maimonides Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/22906960
Description
pubmed abstract

Learn more about this trial

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

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