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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504817-56 | Other Identifier | EMA CTIS NR |
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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 88% oxygen saturation threshold | Experimental | Patients in this arm will receive supplemental oxygen when SpO2 falls below 88% or when other clinical symptoms indicate a need for supplemental oxygen. |
|
| 92% oxygen saturation threshold | Active Comparator | Patients in this arm will receive supplemental oxygen when SpO2 falls below 92% or when other clinical symptoms indicate a need for supplemental oxygen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen saturation threshold | Other | Oxygen saturation threshold on which supplemental oxygen is decided |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to meeting all discharge criteria | Time in hours from admission to meeting all discharge criteria Discharge criteria include:
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Skin type influence | Investigation in to the influence of skin type on safety and effectiveness outcomes | 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. |
Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sam Louman, MD | Contact | +3123-2241645 | slouman@spaarnegasthuis.nl |
| Name | Affiliation | Role |
|---|---|---|
| Annmeie LM Boehmer, MD, PhD | Spaarne Gasthuis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaarne Gasthuis | Recruiting | Haarlem | North Holland | 2035 RC | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42119581 | Derived | Louman S, van Stralen KJ, Koppelman GH, Vaessen-Verberne AAPH, Bekhof J, Bosmans JE, Brackel CLH, Kamps AWA, de Kleer IM, Mulder CFL, Balemans W, Scheffer-Rath M, Brouwer ML, van den Beukel ME, Akkermans MD, Twisk JWR, Vijsma D, Doganer E, Pijnenburg MWH, Boehmer ALM. Oxygen saturation thresholds in children with acute respiratory distress (OxyKids): a multicentre, open, parallel-group, randomised clinical trial. Lancet Respir Med. 2026 May 12:S2213-2600(26)00087-1. doi: 10.1016/S2213-2600(26)00087-1. Online ahead of print. | |
| 39806594 |
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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.
The data will only be made available for reuse after completion of the study and all planned publications of the results.
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.
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Randomized controlled trial, parallel group, block randomized and stratified by age and centre.
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| 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 |
| recorded at discharge based on monitoring data registered during admission, generally a few days to a week but longer if admission lasts longer. |
| Canisius Wilhelmina Ziekenhuis | Recruiting | Arnhem | Netherlands |
|
| Rijnstate Ziekenhuis | Recruiting | Arnhem | Netherlands |
|
| Amphia Ziekenhuis | Recruiting | Breda | Netherlands |
|
| Martini Ziekenhuis | Recruiting | Groningen | Netherlands |
|
| Tergooi Ziekenhuis | Recruiting | Hilversum | Netherlands |
|
| St Antonius Ziekenhuis | Recruiting | Nieuwegein | Netherlands |
|
| Franciscus Gasthuis en Vlietland | Recruiting | Rotterdam | Netherlands |
|
| Isala Klinieken | Recruiting | Zwolle | Netherlands |
|
| Derived |
| Louman S, van Stralen KJ, Koppelman G, Vaessen-Verberne A, Bekhof J, Bosmans J, Brackel C, Kamps AWA, de Kleer I, Balemans W, Scheffer M, Brouwer M, van den Beukel M, Andrinopoulou ER, Pijnenburg MWH, Boehmer ALM. Safe, effective and cost-effective oxygen saturation targets for children and adolescents with respiratory distress: protocol for a randomised controlled trial (OxyKids study). BMJ Open. 2024 Dec 22;14(12):e087891. doi: 10.1136/bmjopen-2024-087891. |
| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| D016535 | Bronchial Hyperreactivity |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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