Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial
NCT ID: NCT06016244
Last Updated: 2024-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
560 participants
INTERVENTIONAL
2023-09-04
2025-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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88% oxygen saturation threshold
Patients in this arm will receive supplemental oxygen when SpO2 falls below 88% or when other clinical symptoms indicate a need for supplemental oxygen.
Oxygen saturation threshold
Oxygen saturation threshold on which supplemental oxygen is decided
92% 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.
Oxygen saturation threshold
Oxygen saturation threshold on which supplemental oxygen is decided
Interventions
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Oxygen saturation threshold
Oxygen saturation threshold on which supplemental oxygen is decided
Eligibility Criteria
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Inclusion Criteria
* 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 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.
6 Weeks
12 Years
ALL
No
Sponsors
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Spaarne Gasthuis
OTHER
Responsible Party
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Principal Investigators
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Annmeie LM Boehmer, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Spaarne Gasthuis
Locations
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Spaarne Gasthuis
Haarlem, North Holland, Netherlands
Canisius Wilhelmina Ziekenhuis
Arnhem, , Netherlands
Rijnstate Ziekenhuis
Arnhem, , Netherlands
Amphia Ziekenhuis
Breda, , Netherlands
Martini Ziekenhuis
Groningen, , Netherlands
Tergooi Ziekenhuis
Hilversum, , Netherlands
St Antonius Ziekenhuis
Nieuwegein, , Netherlands
Franciscus Gasthuis en Vlietland
Rotterdam, , Netherlands
Isala Klinieken
Zwolle, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2023-504817-56
Identifier Type: OTHER
Identifier Source: secondary_id
2022.0100
Identifier Type: -
Identifier Source: org_study_id
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