Premature Birth Clinical Trial
Official title:
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)
NCT number | NCT00187434 |
Other study ID # | 240-2003 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | September 14, 2005 |
Last updated | January 22, 2007 |
Start date | September 2003 |
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.
Status | Recruiting |
Enrollment | 76 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook & Women's College Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre | Ontario Lung Association |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | reintubation | |||
Secondary | length of time in days on CPAP | |||
Secondary | corrected gestational age at cessation of CPAP | |||
Secondary | average weight gain on CPAP | |||
Secondary | assessment of pain will |
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