Comparison of Two Methods of Continuous Positive Airway Pressure (CPAP) to Support Successful Extubation of Infants of Birth Weights ≤ 1500 Grams (C2CPAP)

January 22, 2007 updated by: Sunnybrook Health Sciences Centre

A Randomized Control Trial Comparing Two Methods of Delivering Continuous Positive Airway Pressure (CPAP), Infant Flow System CPAP and Bubble CPAP, in Supporting Successful Extubation of Infants of Birth Weights Less Than or Equal to 1500 Grams at Birth (C2CPAP)

Continuous positive airway pressure (CPAP) has been used successfully to promote extubation in the premature infant population. The two methods of CPAP to be examined are currently used by many institutions, yet no study has compared these methods to determine which is better in the population of newborns < 1500 grams (birth weight) at supporting extubation. This randomised controlled study will examine two types of CPAP: the Infant Flow System and the Bubble CPAP. This randomised controlled, single site, clinical study is to determine whether the Bubble CPAP or the Infant Flow System (IFS) CPAP is more effective at supporting the extubation in infants of birth weights < 1500 grams. Seventy-six infants will be randomised, immediately prior to extubation, to IFS or Bubble CPAP of 5 cmH2O. The primary outcome is successful extubation, defined as not reaching failure criteria for the 7 days post-extubation. Failure criteria are defined as pH < 7.25 and PCO2 > 65 mmHg or a sustained increase in FiO2 of 0.15.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Background: Continuous Positive Airway Pressure (CPAP) has been used successfully to promote extubation in the premature infant population (Davis & Henderson-Smart, 2002). The two methods of CPAP to be examined are used by many institutions, yet no study has compared these methods to determine which is better in the population of newborns < 1500 grams (birth weight) at supporting extubation. This study may have cost savings implications. If bubble CPAP is shown to be as effective in this application neonatal intensive care units (NICUs) will have a more affordable option of providing effective CPAP.

Methods: This randomised controlled, single site, clinical study is to determine if Bubble CPAP or Infant Flow System (IFS) CPAP is more effective at supporting extubation in infants of birth weights < 1500 grams. Seventy-six infants will be randomised immediately prior to extubation to IFS or Bubble CPAP of 5 cmH2O. The primary outcome is successful extubation, defined as not reaching failure criteria for the 7 days post-extubation. Failure criteria are defined as pH < 7.25 and PCO2 > 65 mmHg or a sustained increase in FiO2 of 0.15.

Participants: Parents/guardians of eligible infants will be approached and given information regarding the study, and any questions answered. They will then be allowed to consider study participation in private. The recruiter will return at an agreed time and informed consent will be obtained from those agreeing to participate. Parents will be approached in accordance with the guidelines of the NICU @ SWCHSC. Infants are eligible if birth weight < 1500 grams, are to be extubated to CPAP and have no known airway anomalies, or suspected genetic anomalies.

Analysis: Multiple ANOVA analysis will be used for continuous variables, chi-square for categorical variables, including primary outcome.

Conclusion: The results of this study will determine which method of CPAP is the best method of supporting extubation in the < 1500 g infant.

Study Type

Interventional

Enrollment

76

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4L 2Y6
        • Recruiting
        • Sunnybrook & Women's College Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Marilyn D Hyndman

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Intubated infant
  • ≤ 1500 grams at birth
  • Decision to extubate to CPAP made by the clinical team
  • Written informed consent obtained

Exclusion Criteria:

  • Have known airway anomalies
  • Have grade III or IV or periventricular leukomalacia
  • Have known or suspected genetic syndromes

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
failure of extubation as defined by the following: pH < 7.25 and PCO2 > 65 (or an increase of 15 mmHg from pre-extubation), a sustained (> 1 hour) increase in FiO2 of .15 (as compared to pre-extubation) or significant apno

Secondary Outcome Measures

Outcome Measure
reintubation
length of time in days on CPAP
corrected gestational age at cessation of CPAP
average weight gain on CPAP
assessment of pain will

Collaborators and Investigators

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

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Ontario Lung Association

Investigators

  • Principal Investigator: Marilyn D Hyndman, Sunnybrook & Women's College Health Sciences Centre

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

September 1, 2003

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

January 23, 2007

Last Update Submitted That Met QC Criteria

January 22, 2007

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 240-2003

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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