Prolonged administration of closed-loop inspired oxygen support in preterm infants A randomised clinical trial
Phase 3
Completed
- Conditions
- hypoxie en hyperoxie bij prematuriteitneonatal hypoxia and hyperoxia
- Registration Number
- NL-OMON48688
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
* From day 7 of life after being born with a gestational age under 28 weeks
* Desaturation lower than 86% at least 8 times per day and/or a structural need
of supplemental oxygen > 25%
* Written informed parental consent
Exclusion Criteria
* Major congenital anomalies
* If the attending physician deems participation in the study is not in the
best interest of the infant
* No ventilator with A-FiO2 function available
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome variable will be the proportion of time for both control<br /><br>settings with SpO2 within the assigned saturation TR (90-95%), measured over a<br /><br>time period of a month.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes will be the proportion of time being in hypoxemia or<br /><br>hyperoxemia, distribution of SpO2 between the different settings, and<br /><br>cumulative amount of oxygen administered over 28 days and at final study day.</p><br>