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

NCT00187434 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2007-01-23

No results posted yet for this study

Summary

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.

Conditions

  • Premature Birth
  • Respiratory Insufficiency

Interventions

DEVICE

Infant Flow System

DEVICE

Bubble CPAP

Sponsors & Collaborators

  • Ontario Lung Association

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Marilyn D Hyndman · Sunnybrook & Women's College Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00187434 on ClinicalTrials.gov