Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial

Study Overview
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Brief Summary
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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?

Official Title
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Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial

Conditions
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Bronchial Hyperreactivity, Bronchiolitis, Lower Respiratory Tract Infection

Intervention / Treatment
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* Other: Oxygen saturation threshold


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial, parallel group, block randomized and stratified by age and centre.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 88% oxygen saturation threshold<br>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<br>* Oxygen saturation threshold on which supplemental oxygen is decided<br>|
| Active Comparator: 92% oxygen saturation threshold<br>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<br>* Oxygen saturation threshold on which supplemental oxygen is decided<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to meeting all discharge criteria | Time in hours from admission to meeting all discharge criteria | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Time from admission to discharge in hours | During admission | 
| Pediatric Intensive Care Unit (PICU) admissions | Number of PICU admissions per group | During admission | 
| Time on oxygen therapy | Time in hours spent on supplemental oxygen | 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. | 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 | 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 | 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 | 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) | at discharge, 7, 28 and 90 days follow-up | 
| Overall pediatric health | ICHOM PROMIS Pediatric Global Health set | at discharge, 7, 28 and 90 days follow-up | 
| Parental anxiety | by anxiety items of Hospital Anxiety and Depression Scale | 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 | Up to 90 days after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxygen saturation target, SpO2, Children