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Optimising Oxygenation of Preterm infants during Respiratory support by fine-tuning Automatic TItration of Oxygen

Optimising Oxygenation of Preterm infants during Respiratory support by fine-tuning Automatic TItration of Oxygen - OPeRATIOn

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50861
Enrollment
27
Registered
2021-07-27
Start date
2021-10-09
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Respiratory distress ventilation

Interventions

In both groups supplemental oxygen will be titrated by the OxyGenie automated oxygen controller for 25 hours, either titrated to a target range of 91%-95% or 92%-96%. Automated oxygen control aimed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Born between 24-32 weeks of gestation receiving respiratory support and supplemental oxygen (at least 25%), with written informed parental consent.

Exclusion criteria

Exclusion criteria: Major congenital anomalies or arterial hypotension requiring vasopressor therapy within 48 hours prior to enrolment.

Design outcomes

Primary

MeasureTime frame
To compare the effect of two target ranges (91%-95% and 92%-96%) while on automated oxygen control while using the OxyGenie controller on the frequency of hypoxic episodes (SpO2

Secondary

MeasureTime frame
- To compare the effect of two target ranges (91%-95% and 92%-96%) while on automated oxygen control by using the OxyGenie controller on parameters of oxygenation: a) Distribution of oxygen saturation (the SpO2 histogram). b) Proportion of time in hypoxaemia and hyperoxaemia (varying degrees). c) Frequency and duration of hypoxaemic and hyperoxaemic episodes, and of bradycardia. (defined as a heartrate

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)