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Markers of Oxidative Stress from Supplemental Oxygen in critically-ill children

Markers of Oxidative Stress from Supplemental Oxygen in critically-ill children - MOSSO2

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56664
Enrollment
32
Registered
2021-09-24
Start date
Unknown
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

bronchiolitis lower respiratory tract infection

Interventions

No investigational product is administered. Two short term oxygenation protocols will be used during ongoing mechanical ventilation as part of usual clinical care.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
No minimum to 11 Years

Inclusion criteria

Inclusion criteria: Main study population: - Age below 24 months - Proven VLRTI - Endotracheal intubation - Mechanical ventilation - Informed consent obtained for the complete study protocol (3 days) of exposure to two different oxygen supplementation protocols on separate days combined with non-invasive exhaled-breath measurements and a single non-endoscopic bronchoalveolar lavage at the final day of study after confirmation of comprehension of the Dutch language Non-infected control population: - Age below 12 years - Endotracheal intubation - Mechanical ventilation - No signs of infection (fever, temperature >38.5 C) and no respiratory symptoms (cough, wheeze, snotty) present at moment of intubation - No reported respiratory symptoms in the last seven days prior to pediatric intensive care unit admission - Informed consent obtained for the partial study protocol (1 day) of exposure to the liberal oxygenation protocol combined with non-invasive exhaled-breath measurements after confirmation of comprehension of the Dutch language

Exclusion criteria

Exclusion criteria: Main study population: - Age above 24 months - Active infection with SARS-CoV-2 - Contra-indication for high flow or low flow oxygen supplementation (e.g. previous bleomycin treatment, carbon monoxide intoxication) - No consent - Receiving HFO - Receiving nitric oxide treatment for pulmonary hypertension - In need for specific oxygen saturation targets based on underlying congenital heart disease Non-infected control population: - Age above 12 years - Proven ongoing pulmonary infection - Symptoms of a present or recent infection (temperature >38.5 C) or respiratory symptoms (cough, wheeze, snotty) in the last seven days prior to pediatric intensive care unit admission. - Contra-indication for high flow oxygen supplementation (e.g. previous bleomycin treatment) - No consent

Design outcomes

Primary

MeasureTime frame
The main study parameters of part 1) are markers of oxidative stress as measured by volatile organic compounds from exhaled breath in vivo. The main study parameters of part 2) are markers of oxidative stress and cellular injury in vitro.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)