Comparison of Two Methods of Continuous Positive Airway Pressure (CPAP) to Support Successful Extubation of Infants of Birth Weights ≤ 1500 Grams (C2CPAP)
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)
1 other identifier
interventional
76
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for not_applicable
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedJanuary 23, 2007
September 1, 2005
September 14, 2005
January 22, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
reintubation
length of time in days on CPAP
corrected gestational age at cessation of CPAP
average weight gain on CPAP
assessment of pain will
Interventions
Eligibility Criteria
You may qualify if:
- Intubated infant
- ≤ 1500 grams at birth
- Decision to extubate to CPAP made by the clinical team
- Written informed consent obtained
You may not qualify if:
- Have known airway anomalies
- Have grade III or IV or periventricular leukomalacia
- Have known or suspected genetic syndromes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sunnybrook Health Sciences Centrelead
- Ontario Lung Associationcollaborator
Study Sites (1)
Sunnybrook & Women's College Health Sciences Centre
Toronto, Ontario, M4L 2Y6, Canada
Related Publications (1)
Ho JJ, Zakarija-Grkovic I, Lok JW, Lim E, Subramaniam P, Leong JJ. Continuous positive airway pressure (CPAP) for apnoea of prematurity. Cochrane Database Syst Rev. 2023 Jul 18;7(7):CD013660. doi: 10.1002/14651858.CD013660.pub2.
PMID: 37481707DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marilyn D Hyndman
Sunnybrook & Women's College Health Sciences Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 16, 2005
Study Start
September 1, 2003
Last Updated
January 23, 2007
Record last verified: 2005-09