Recruiting

CPAP Comparison

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT00187434

Conditions

Premature Birth

Respiratory Insufficiency

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Infant Flow System

Bubble CPAP

Study Details

Brief 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

Study ID

NCT00187434

Start date

Sep, 2003

Status verified date

Sep, 2005

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

76 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Infant Flow System

Bubble CPAP

Primary 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 [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Locations

Sunnybrook & Women's College Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4L 2Y6

Contacts

Principal Investigator:

Marilyn D Hyndman

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Jan 23, 2007

Last verified

Sep, 2005

Keywords

  • premature infant
  • supporting extubation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2007-01-23.