An interventional study of Oxygen saturation threshold in Bronchiolitis, Lower Respiratory Tract Infection and Bronchial Hyperreactivity, sponsored by Spaarne Gasthuis. Completed at 9 sites in Netherlands. Open to participants aged 6 Weeks to 12 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Spaarne Gasthuis · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to find out at which lower limit for saturation (amount of oxygen in the blood) we can best give extra oxygen to children that have been admitted for shortness of breath. We hope to accomplish a shorter period of illness for these children and that they can be discharged home earlier. Participants will receive supplemental oxygen if their blood oxygen levels are below 88% or below 92%. After admission, (parents of) participating children will fill out questionnaires. We will compare the two groups on their hospitalization duration and recovery.
In other words, is it better to maintain a lower limit of 88% saturation or a lower limit of 92% in children admitted for shortness of breath?
289 studies on the registry are indexed under Bronchiolitis; 51 are open to participants now.
This study's enrollment of 566 is above the median of 100 across 195 interventional studies indexed under Bronchiolitis.
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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:
Patients in this arm will receive supplemental oxygen when SpO2 falls below 88% or when other clinical symptoms indicate a need for supplemental oxygen.
Other: Oxygen saturation threshold
Patients in this arm will receive supplemental oxygen when SpO2 falls below 92% or when other clinical symptoms indicate a need for supplemental oxygen.
Other: Oxygen saturation threshold
Oxygen saturation threshold on which supplemental oxygen is decided
Time to meeting all discharge criteria
Time in hours from admission to meeting all discharge criteria Discharge criteria include: * No need for supplemental oxygen for 4 hours, including a period of sleep for children aged \< 2 years * Clinically fit for discharge with normal or minimally increased respiratory rate AND no or mild respiratory distress, as judged by nurses and physicians using the Parshuram et al scoring system, commonly used in Dutch paediatric practice as part of the Pediatric Early Warning Scale\]. * No need for in-hospital feeding or medication by nasogastric tube (NGT). * No need for in-hospital intravenous treatment. * No need for in-hospital nebulized bronchodilator treatment. * No need for in-hospital treatment with metered dose inhalator inhalations more often than every 3 hours. * No need for high flow delivered by high flow nasal cannula or nasal prongs.
Time frame: Discharge criteria are checked daily during admission up to discharge (generally a few days up to a week but longer if admission lasts longer) and the time and date at which all discharge criteria have been met will be recorded.
Length of stay
Time from admission to discharge in hours
Time frame: During admission
Pediatric Intensive Care Unit (PICU) admissions
Number of PICU admissions per group
Time frame: During admission
Time on oxygen therapy
Time in hours spent on supplemental oxygen
Time frame: During admission
Duration of symptoms
Measured as days from admission to having met all of the following criteria: resolution of cough, resolution of dyspnea as indicated by parent, cessation of scheduled bronchodilator use.
Time frame: from admission to 90 days after discharge
Return to normal health
Measured as days from admission to parent reported normal health. Upon discharge parents/patients are asked to record the last day of illness and report this in the follow-up questionnaires
Time frame: from admission to 90 days after discharge
Time to return to school/daycare
Measured as days from admission to parent reported return to school/daycare
Time frame: from admission to 90 days after discharge
Unscheduled health care visits or admissions after discharge
Number of unscheduled visits or admissions up to 28 days after discharge
Time frame: from admission to 28 days after discharge
Patient quality of life
Measured by digital questionnaire of EQ-5D-Y (modified versions are used in agreement with EuroQol for patients \< 4 years)
Time frame: at discharge, 7, 28 and 90 days follow-up
Overall pediatric health
ICHOM PROMIS Pediatric Global Health set
Time frame: at discharge, 7, 28 and 90 days follow-up
Parental anxiety
by anxiety items of Hospital Anxiety and Depression Scale
Time frame: at discharge, 7 and 28 days follow-up
Economic evaluation
The aim of the economic evaluation is to relate the incremental costs of an SpO2 of 88% (intervention) in comparison with an SpO2 of 92% (control) to the incremental health effects. Both a cost-effectiveness analysis (CEA) and a cost-utility analysis (CUA) will be performed from a societal and healthcare perspective
Time frame: Up to 90 days after discharge
Skin type influence
Investigation in to the influence of skin type on safety and effectiveness outcomes
Time frame: Up to 90 days after discharge
Time spent in 88%-92% window
Time spent in 88%-92% saturation window, measured by extracted continous monitoring data from patients where this is technically a possibility.
Time frame: recorded at discharge based on monitoring data registered during admission, generally a few days to a week but longer if admission lasts longer.
Plan to share: Yes — Data and metadata will be made available for reuse after removing data from participants who did not consent to reuse of their data and removing any potentially identifiable data. Data archiving and sharing will be done through DANS EASY. The Dublin Core metadata scheme will be used.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: The data will only be made available for reuse after completion of the study and all planned publications of the results.
Access criteria: Other researchers will be able to find the metadata in the data repository. They could express their interest in the dataset through emailing the PI. After meeting the sharing and reuse conditions and approval of the PI, data access will be provided through the data repository.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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