Efficacy and safety of targeting lower arterial oxygen saturations to reduce oxygen toxicity and oxidative stress in very preterm infants: the Canadian Oxygen Trial
Completed
- Conditions
- Respiratory insufficiency of prematurityPregnancy and Childbirth
- Registration Number
- ISRCTN62491227
- Lead Sponsor
- McMaster University (Canada)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1200
Inclusion Criteria
1. Gestational age 23^0/7 to 27^6/7 weeks
2. Postnatal age less than 24 hours, either sex
Exclusion Criteria
1. Infant not considered viable
2. Dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment
3. Known or strongly suspected cyanotic heart disease
4. Persistent pulmonary hypertension
5. Unlikely to be available for long-term follow-up
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Survival without severe neurosensory disability to 18 to 21 months (corrected for prematurity)
- Secondary Outcome Measures
Name Time Method 1. Retinopathy of prematurity measured at 32 to 44 weeks postmenstrual age<br>2. Bronchopulmonary dysplasia measured at 36 weeks postmenstrual age<br>3. Brain injury, measured from the week one of life up to 36 weeks postmenstrual age<br>4. Patent ductus arteriosus, measured until first discharge to home<br>5. Necrotising enterocolitis measured until first discharge to home<br>6. Growth, measured until a corrected age of 18 to 21 months<br>7. Respiratory morbidity, measured until a corrected age of 18 to 21 months<br>8. Mean developmental index scores on the Bayley Scales measured at the corrected age of 18 to 21 months