Efficacy and Safety of Targeting Lower Arterial Oxygen Saturations to Reduce Oxygen Toxicity and Oxidative Stress in Very Preterm Infants
- Conditions
- Study population: Children born extremely preterm (before 28 weeks of gestation). Primary outcome: 1) Death before a corrected age of 18 months and survival with severe disability. 2) The growth of the brain cortex using NMR at term.3) The neurodevelopmental outcome at 8–10 years of age.Secondary outcome: Retinopathy of prematurity, bronchopulmonary dysplasia and brain injury as well as growth, general and cardiopulmonary health to corrected age of 18 months.MedDRA version: 9.1Level: LLTClassification code 10036615Term: Prematurity
- Registration Number
- EUCTR2008-001368-35-FI
- Lead Sponsor
- Oulu University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1200
Inclusion Criteria
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method