30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants
Phase 1
- Conditions
- PrematurityTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- CTIS2023-509780-25-00
- Lead Sponsor
- niversity College Cork
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 700
Inclusion Criteria
Infants with gestational age between 23 to 28 weeks based on best available obstetrical estimate, Infants designated to receive full resuscitation, i.e., no parental request or pre-determined decision to forego resuscitation, No known major congenital or chromosomal malformation.
Exclusion Criteria
Infant born outside of study centers and transported to center after delivery, Parents’ refusal to give consent to this study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method