Could a lower oxygen threshold get kids home sooner?

NCT ID NCT06016244

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This trial tests whether using a lower oxygen saturation threshold (88%) versus the standard (92%) to decide when to give supplemental oxygen helps children aged 6 weeks to 12 years recover faster from respiratory distress. Participants are randomly assigned to one of two groups, and researchers measure how long it takes to meet discharge criteria. The goal is to find a safe, cost-effective approach that shortens hospital stays.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oxygen saturation threshold (88% or 92%) for deciding when to give supplemental oxygen
What this could lead to
If successful, this could establish a safe, cost-effective oxygen target that shortens hospital stays and speeds recovery for children with breathing problems.
What could go wrong
This is a single-center trial, and results may not apply to all hospitals or children. The lower threshold (88%) might not be safe for every child, and the study may not detect rare complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

566 people

The number who actually took part.

Started

Sep 2023

Finished

Apr 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 weeks to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Amphia Ziekenhuis

    Breda, Netherlands

  • Canisius Wilhelmina Ziekenhuis

    Arnhem, Netherlands

  • Franciscus Gasthuis en Vlietland

    Rotterdam, Netherlands

  • Isala Klinieken

    Zwolle, Netherlands

  • Martini Ziekenhuis

    Groningen, Netherlands

  • Rijnstate Ziekenhuis

    Arnhem, Netherlands

  • Spaarne Gasthuis

    Haarlem, North Holland, 2035 RC, Netherlands

  • St Antonius Ziekenhuis

    Nieuwegein, Netherlands

  • Tergooi Ziekenhuis

    Hilversum, Netherlands

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