Respiratory Insufficiency of Prematurity
Conditions
Keywords
oxygen therapy, neurodevelopmental impairment
Brief summary
Study Question: In infants who are born at gestational ages of 23 0/7 to 27 6/7 weeks, does lowering the concentration of supplemental oxygen to target an arterial oxygen saturation by pulse oximetry (SpO2)of 85-89% compared with 91-95%, from the day of birth until the baby's first discharge home, increase the probability of survival without severe neurosensory disability to a corrected age of 18 months?
Detailed description
Most extremely preterm babies require supplemental oxygen for several weeks or even months after birth. The goal of oxygen therapy is to achieve adequate oxygen delivery to the tissues without causing oxygen toxicity and oxidative stress. At present, this goal is elusive in very immature infants. Although it is standard practice in modern neonatal intensive care units to monitor arterial oxygen saturations via pulse oximetry, there is insufficient evidence to guide the choice of the upper and lower alarm limits. A rigorous trial with long-term follow up is urgently needed and long overdue to determine whether oxygen exposure can be reduced safely in extremely preterm infants without increasing the risk of hypoxic death or disability.
Interventions
OTHERTitration of oxygen therapy
Supplemental oxygen to maintain functional arterial oxygen saturations in one of two saturation target ranges.
Sponsors
Canadian Institutes of Health Research (CIHR)
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Hours
Healthy volunteers
No
Inclusion criteria
* Gestational age 23 0/7 - 27 6/7 weeks * Postnatal age \< 24 hours
Exclusion criteria
* Infant not considered viable (decision made not to administer effective therapies) * Dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment * Known or strongly suspected cyanotic heart disease * Persistent pulmonary hypertension, e.g. associated with pulmonary hypoplasia * Unlikely to be available for long-term follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival without severe neurosensory disability to 18 to 21 months (corrected for prematurity) | 18-21 months corrected for prematurity |
Secondary
| Measure | Time frame |
|---|---|
| Bronchopulmonary dysplasia | 36 weeks postmenstrual age |
| Brain injury | from week one of life up to 36 weeks postmenstrual age |
| Patent ductus arteriosus | until first discharge home |
| Retinopathy of prematurity | 32 to 44 weeks postmenstrual age |
| Growth | until 18-21 months corrected for prematurity |
| respiratory morbidity | until 18-21 months corrected for prematurity |
| Mean developmental index scores on the Bayley Scales | 18-21 months corrected for prematurity |
| Necrotizing enterocolitis | until first discharge home |
Countries
Argentina, Canada, Finland, Germany, Israel, United States
Outcome results
None listed