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Prolonged administration of closed-loop inspired oxygen support in preterm infants A randomised clinical trial

Prolonged administration of closed-loop inspired oxygen support in preterm infants A randomised clinical trial - OptiClio 2 study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48688
Enrollment
40
Registered
2017-11-01
Start date
2018-05-30
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

hypoxie en hyperoxie bij prematuriteit neonatal hypoxia and hyperoxia

Interventions

In order to study the effectiveness over a longer period of time of the A-FiO2 function of the ventilator, preterm infants will be set at random to either continuous use of the A-FiO2 function or to

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The primary outcome variable will be the proportion of time for both control settings with SpO2 within the assigned saturation TR (90-95%), measured over a time period of a month.

Secondary

MeasureTime frame
Secondary outcomes will be the proportion of time being in hypoxemia or hyperoxemia, distribution of SpO2 between the different settings, and cumulative amount of oxygen administered over 28 days and at final study day.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)