Comparing Weaning of Nasal Continuous Positive Airway Pressure (CPAP) From Preterm Infants

June 6, 2016 updated by: Maimonides Medical Center

Randomized Control Trial of Weaning NCPAP From Preterm Infants: Sudden Wean Versus Weaning by Gradually Decreasing Pressure

To compare the 2 methods of weaning of nasal continuous positive airway pressure (CPAP) in premature babies born between 26 and 32 weeks

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To study the weight and the post menstrual age (PMA) at the time of 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 between 26 and 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)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11219
        • Maimonides medcial center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 neonates born 26 to 32 weeks of gestational age

Exclusion Criteria:

  • Those with severe congenital anomalies and chromosomal defects including congenital heart disease, neurological malformations, chest and airway abnormalities and lung hypoplasia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Sudden wean
When ready Nasal Continuous Positive Airway Pressure (NCPAP) will be removed from the neonate
Active Comparator: Gradual pressure wean
NCPAP will be removed by gradually decreasing pressure over 24 hours once the weaning is decided
Other: Gradual pressure wean
NCPAP will be removed by gradually decreasing pressure over 24 hours once the weaning is decided

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success of weaning on first trial off NCPAP
Time Frame: Completion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks
Completion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Weight and corrected GA when come off oxygen
Time Frame: when off supplemental oxygen expected average of 2 weeks
when off supplemental oxygen expected average of 2 weeks
Weight and corrected gestational age (GA) when neonates could come off NCPAP
Time Frame: Completion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks
Completion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks

Other Outcome Measures

Outcome Measure
Time Frame
length of stay in the neonatal intensive care unit
Time Frame: when ready to be discharged, expected average of 6-8 weeks
when ready to be discharged, expected average of 6-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maimonides Medical Center

Investigators

  • Principal Investigator: Shantanu Rastogi, MD, Maimonides Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 17, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (Estimate)

April 30, 2014

Study Record Updates

Last Update Posted (Estimate)

June 8, 2016

Last Update Submitted That Met QC Criteria

June 6, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMC 13/01/VA03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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