Effects of closed-loop automatic control of inspiratory fraction of oxygen (FiO2-C) on outcome of extremely preterm infants-a randomized controlled parallel group multicenter trial for safety and efficacy.
Recruiting
- Conditions
- vroeggeboorteprematurity
- Registration Number
- NL-OMON54702
- Lead Sponsor
- niversity Hospital Tübingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
Preterm infant born at gestational age 24-28 weeks
Exclusion Criteria
Palliative care Congenital anomalies Postnatal age >48 hours No parental
consent No device with automatic FiO2 control
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Composite outcome of death, severe retinopathy of prematurity (ROP), chronic<br /><br>lung disease or necrotizing enterocolitis until 36 weeks PMA (or, for ROP,<br /><br>until full vascularization of the retina).<br /><br><br /><br>Composite outcome of death, language/ cognitive delay, motor impairment, severe<br /><br>visual impairment or hearing impairment at 24 months corrected age.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Individual components of the primary outcome variables and developmental scores<br /><br>of the Bayley Scales of Infant Development (3rd edition)<br /><br><br /><br>In selected centers only: time within the oxygen saturation target range,<br /><br>median FiO2, number of manual FiO2 adjustments, time of regional cerebral<br /><br>oxygenation within target range, cerebral volumes and brain injury by MRI at<br /><br>term equivalent age.</p><br>