Respiratory insufficiency of prematurity Pregnancy and Childbirth Respiratory insufficiency of prematurity
Conditions
Interventions
Exerimental arm: supplemental oxygen to maintain functional arterial oxygen saturations in the range of 85-89%. Dose of oxygen is determined by the individual infant's need to achieve the target oxyge
Sponsors
McMaster University (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Gestational age 23^0/7 to 27^6/7 weeks 2. Postnatal age less than 24 hours, either sex
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Survival without severe neurosensory disability to 18 to 21 months (corrected for prematurity) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Retinopathy of prematurity measured at 32 to 44 weeks postmenstrual age 2. Bronchopulmonary dysplasia measured at 36 weeks postmenstrual age 3. Brain injury, measured from the week one of life up to 36 weeks postmenstrual age 4. Patent ductus arteriosus, measured until first discharge to home 5. Necrotising enterocolitis measured until first discharge to home 6. Growth, measured until a corrected age of 18 to 21 months 7. Respiratory morbidity, measured until a corrected age of 18 to 21 months 8. Mean developmental index scores on the Bayley Scales measured at the corrected age of 18 to 21 months | — |
Countries
Argentina, Canada, Finland, Germany, Norway
Outcome results
None listed