Determining the best oxygen levels for children with breathing difficulties
Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial
This study is trying to find the best oxygen levels for children with breathing problems to see if it helps them recover faster and spend less time in the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 560 (estimated) |
| Ages | 6 Weeks to 12 Years |
| Sex | All |
| Sponsor | Spaarne Gasthuis Academic / other |
| Locations | 9 sites (Haarlem, Noord-Holland and 8 other locations) |
| Trial ID | NCT06016244 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to identify the optimal lower limit of oxygen saturation for children and adolescents experiencing respiratory distress. Participants will be randomly assigned to receive supplemental oxygen if their blood oxygen levels fall below either 88% or 92%. The study will evaluate the duration of hospitalization and recovery outcomes between the two groups. By comparing these thresholds, the trial seeks to establish a safe and effective approach to managing oxygen levels in young patients with respiratory issues.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 weeks to 12 years who are hospitalized with respiratory distress due to bronchiolitis or lower respiratory tract infections.
Not a fit: Patients with pre-existing cardiopulmonary, neurological, or hematological conditions, as well as those experiencing asthma attacks, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of oxygen therapy in children, potentially reducing hospitalization time and enhancing recovery.
How similar studies have performed: Other studies have explored oxygen saturation levels in pediatric populations, but this specific approach to comparing two distinct saturation thresholds is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 6 weeks to 12 years of age (corrected age for children with gestational age \< 37 weeks) * hospitalized with respiratory distress due to bronchiolitis, viral wheeze or lower respiratory tract infection, as diagnosed by the treating physician. Viral wheeze can only be diagnosed below the age of 6 years. * requiring supplemental oxygen as per usual care (SpO2 \<92% or for treating symptoms of respiratory distress as determined by the treating physician As respiratory distress in children with an asthma attack is mainly driven by hypoxia, they are at risk of undertreatment in the acute phase of the attack. Therefore, children aged 6-12 years of age with an asthma attack are excluded from this study. Exclusion Criteria: * children with, except for the studied diseases, pre-existing cardiopulmonary, neurological or hematological conditions (e.g. congenital thoracic malformation, airway malacia, post infectious bronchiolitis obliterans, childhood interstitial lung disease. primary immune deficiency) * children born \<32 weeks gestational age * children already included in other studies, which potentially interfere with this study * children (of parents) without a stable internet connection needed for answering questionnaires * children previously included in the current study * considering questionnaires are only available in Dutch and English, children (of parents) with different languages will be excluded.
Where this trial is running
Haarlem, Noord-Holland and 8 other locations
- Spaarne Gasthuis — Haarlem, Noord-Holland, Netherlands (Recruiting)
- Canisius Wilhelmina Ziekenhuis — Arnhem, Netherlands (Recruiting)
- Rijnstate Ziekenhuis — Arnhem, Netherlands (Recruiting)
- Amphia Ziekenhuis — Breda, Netherlands (Recruiting)
- Martini Ziekenhuis — Groningen, Netherlands (Recruiting)
- Tergooi Ziekenhuis — Hilversum, Netherlands (Recruiting)
- St Antonius Ziekenhuis — Nieuwegein, Netherlands (Recruiting)
- Franciscus Gasthuis en Vlietland — Rotterdam, Netherlands (Recruiting)
- Isala Klinieken — Zwolle, Netherlands (Recruiting)
Study contacts
- Principal investigator: Annmeie LM Boehmer, MD, PhD — Spaarne Gasthuis
- Study coordinator: Sam Louman, MD
- Email: slouman@spaarnegasthuis.nl
- Phone: +3123-2241645
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.