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

Withdrawn

• Conditions: bronchiolitis; lower respiratory tract infection; 10047438; 10024967

• Registration Number: NL-OMON56664
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 32

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified