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Completed

NCT Number: NCT06016244

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

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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Key information

Conditions

Bronchiolitis Bronchial Diseases Bronchial Hyperreactivity Bronchitis Infections Lower Respiratory Tract Infection Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

6 week–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spaarne Gasthuis, Haarlem, North Holland, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxygen saturation threshold

Other

Oxygen saturation threshold on which supplemental oxygen is decided

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. Length of stay

    Time frame: During admission

    Time from admission to discharge in hours

  2. Pediatric Intensive Care Unit (PICU) admissions

    Time frame: During admission

    Number of PICU admissions per group

  3. Time on oxygen therapy

    Time frame: During admission

    Time in hours spent on supplemental oxygen

  4. Duration of symptoms

    Time frame: from admission to 90 days after discharge

    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.

  5. Return to normal health

    Time frame: from admission to 90 days after discharge

    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

  6. Time to return to school/daycare

    Time frame: from admission to 90 days after discharge

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

  7. Unscheduled health care visits or admissions after discharge

    Time frame: from admission to 28 days after discharge

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

  8. Patient quality of life

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

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

  9. Overall pediatric health

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

    ICHOM PROMIS Pediatric Global Health set

  10. Parental anxiety

    Time frame: at discharge, 7 and 28 days follow-up

    by anxiety items of Hospital Anxiety and Depression Scale

  11. Economic evaluation

    Time frame: Up to 90 days after discharge

    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

Other outcomes

  1. Skin type influence

    Time frame: Up to 90 days after discharge

    Investigation in to the influence of skin type on safety and effectiveness outcomes

  2. Time spent in 88%-92% window

    Time frame: recorded at discharge based on monitoring data registered during admission, generally a few days to a week but longer if admission lasts longer.

    Time spent in 88%-92% saturation window, measured by extracted continous monitoring data from patients where this is technically a possibility.

Sponsors and collaborators

Lead sponsor

Spaarne Gasthuis

Other

Registry information

Acronym: OxyKids

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 29, 2023
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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