Efficacy and Safety of Targeting Lower Arterial Oxygen Saturations to Reduce Oxygen Toxicity and Oxidative Stress in Very Preterm Infants

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-001368-35-FI

Enrollment

1200

Registered

2008-03-10

Start date

2008-04-24

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 9.1 Level: LLT

Interventions

Trade Name: Oxygen Pharmaceutical Form: Inhalation gas INN or Proposed INN: oxygen

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Main Objective: ;Secondary Objective: ;Primary end point(s):	—

Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026