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BronchiolitisOxyKidsNCT06016244

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

A study testing Oxygen saturation threshold in people with Bronchiolitis and Lower Respiratory Tract Infection, run by Spaarne Gasthuis at 9 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 6 weeks to 12 years
What is being tested?
Oxygen saturation threshold
Could I receive a placebo?
No, everyone receives an active treatment
How many people
566 participants
Where
9 sitesNetherlands
Study dates
4 Sep 2023to 4 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 weeks to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Netherlands9 sites

  • Canisius Wilhelmina Ziekenhuis

    Arnhem

  • Rijnstate Ziekenhuis

    Arnhem

  • Amphia Ziekenhuis

    Breda

  • Martini Ziekenhuis

    Groningen

  • Spaarne Gasthuis

    Haarlem, North Holland, 2035 RC

  • Tergooi Ziekenhuis

    Hilversum

  • St Antonius Ziekenhuis

    Nieuwegein

  • Franciscus Gasthuis en Vlietland

    Rotterdam

  • Isala Klinieken

    Zwolle

Other trials in Netherlands

About this study

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?

Being tested
Oxygen saturation threshold
Keywords
Oxygen saturation target, SpO2, Children
Medical subject headings
Bronchiolitis, Bronchial Hyperreactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxygen saturation thresholdOther

    Oxygen saturation threshold on which supplemental oxygen is decided

Study groups in NCT06016244
Study groupRoleWhat they receive
88% oxygen saturation thresholdExperimentalPatients in this arm will receive supplemental oxygen when SpO2 falls below 88% or when other clinical symptoms indicate a need for supplemental oxygen.
Receives: Other: Oxygen saturation threshold
92% oxygen saturation thresholdActive comparatorPatients in this arm will receive supplemental oxygen when SpO2 falls below 92% or when other clinical symptoms indicate a need for supplemental oxygen.
Receives: Other: Oxygen saturation threshold

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 outcomes (11)

  1. Length of stay

    Time from admission to discharge in hours

    Measured: During admission

  2. Pediatric Intensive Care Unit (PICU) admissions

    Number of PICU admissions per group

    Measured: During admission

  3. Time on oxygen therapy

    Time in hours spent on supplemental oxygen

    Measured: During admission

  4. 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.

    Measured: from admission to 90 days after discharge

  5. 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

    Measured: from admission to 90 days after discharge

  6. Time to return to school/daycare

    Measured as days from admission to parent reported return to school/daycare

    Measured: from admission to 90 days after discharge

  7. Unscheduled health care visits or admissions after discharge

    Number of unscheduled visits or admissions up to 28 days after discharge

    Measured: from admission to 28 days after discharge

  8. Patient quality of life

    Measured by digital questionnaire of EQ-5D-Y (modified versions are used in agreement with EuroQol for patients < 4 years)

    Measured: at discharge, 7, 28 and 90 days follow-up

  9. Overall pediatric health

    ICHOM PROMIS Pediatric Global Health set

    Measured: at discharge, 7, 28 and 90 days follow-up

  10. Parental anxiety

    by anxiety items of Hospital Anxiety and Depression Scale

    Measured: at discharge, 7 and 28 days follow-up

  11. 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

    Measured: Up to 90 days after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2023
  2. Study start4 Sep 2023
  3. Primary completion4 Dec 2024
  4. Study completion4 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial, parallel group, block randomized and stratified by age and centre.
Masking
None (open label)
Enrolment
566 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06016244
Sponsor's protocol ID
2022.0100
Other IDs
2023-504817-56, 2023
Acronym
OxyKids
Status last verified
May 2025
First submitted
31 Jul 2023
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • 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 Aug;14(8):673-682. doi: 10.1016/S2213-2600(26)00087-1. Epub 2026 May 12.

    PubMed 42119581

  • 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.

    PubMed 39806594

Questions about this trial

What is this clinical trial studying?

A study testing Oxygen saturation threshold in people with Bronchiolitis and Lower Respiratory Tract Infection, run by Spaarne Gasthuis at 9 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to meeting all discharge criteria (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06016244, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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