ewborns smaller than normal who will be randomly and blindly assigned to 21% oxygen or 60% oxygen to be resuscitated to investigate the influence upon mortality and chronic conditions in the neonatal period
Phase 1
- Conditions
- Preterm infants aged 30 weeks or less, who need resuscitation / stabilization maneuvers with positive pressure ventilation immediately after birthTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2011-005717-36-ES
- Lead Sponsor
- Instituto de Investigación Sanitaria La Fe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 304
Inclusion Criteria
Preterm infants with gestational age of 30 weeks or less gestation born in tertiary referral centers and needing resuscitation/stabilization maneuvers with positive pressure ventilation immediately after birth
Are the trial subjects under 18? yes
Number of subjects for this age range: 760
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Uncertainty about gestational age
Refusal to participate (parents/guardian)
Not fulfilling study protocol
Decoding in the delivery room
Chromosomopaties
Major malformations
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