Comparison of two methods of continuous positive airway pressure (CPAP) to support successful extubation of infants of birth weights less than or equal to 1500 grams (C2CPAP)
Phase 1
Recruiting
- Conditions
- It has been shown that premature infants are successfully extubated using CPAP. This study compares two popular methods of delivering CPAP to determine if one is more successful at supporting extubation in infants less than or equal to 1500 gram infants.Reproductive Health and Childbirth - Childbirth and postnatal care
- Registration Number
- ACTRN12605000400662
- Lead Sponsor
- Sunnybrook and Women's College Health Sciences Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 76
Inclusion Criteria
1) Intubated infant 2) less than or equal to 1500 grams at birth 3) Decision to extubate to CPAP made by the clinical team 4) Written informed consent obtained.
Exclusion Criteria
Neonates who:1) Have known airway anomalies2) Have grade III or IV or periventricular leukomalacia3) Have known or suspected genetic syndromes.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The failure of extubation as defined by the following: pH less than 7.25 and PCO2 greater than 65 (or an increase of 15 mmHg from pre extubation), a sustained (greater than 1 hour) increase in FiO2 of .15 (as compared to pre extubation) or significant apnoea and bradycardia requiring manual resuscitation at anytime. If these criteria are met within 7 days post extubation this will be considered failure of extubation.[]
- Secondary Outcome Measures
Name Time Method Reintubation[];Length of time in days on CPAP[];Corrected gestational age at cessation of CPAP[];Average weight gain on CPAP[];Pain[The PIPP score is a valid measurement of pain (Stevens, 1996). PIPP scores will be recorded within 24 hours post CPAP initiation.];The presence of nasal tissue damage will also be documented but only as an exploratory question.[]