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

Last updated: October 14, 2024
Sponsor: Spaarne Gasthuis
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bronchitis

Respiratory Syncytial Virus (Rsv) Infection

Bronchitis (Pediatric)

Treatment

Oxygen saturation threshold

Clinical Study ID

NCT06016244
2022.0100
2023-504817-56
  • Ages 6-12
  • All Genders

Study 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. 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?

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 6 weeks to 12 years of age (corrected age for children with gestational age < 37weeks)

  • hospitalized with respiratory distress due to bronchiolitis, viral wheeze or lowerrespiratory tract infection, as diagnosed by the treating physician. Viral wheezecan only be diagnosed below the age of 6 years.

  • requiring supplemental oxygen as per usual care (SpO2 <92% or for treating symptomsof 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

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 interstitiallung disease. primary immune deficiency)

  • children born <32 weeks gestational age

  • children already included in other studies, which potentially interfere with thisstudy

  • children (of parents) without a stable internet connection needed for answeringquestionnaires

  • children previously included in the current study

  • considering questionnaires are only available in Dutch and English, children (ofparents) with different languages will be excluded.

Study Design

Total Participants: 560
Treatment Group(s): 1
Primary Treatment: Oxygen saturation threshold
Phase:
Study Start date:
September 04, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Spaarne Gasthuis

    Haarlem, Noord-Holland 2035 RC
    Netherlands

    Active - Recruiting

  • Canisius Wilhelmina Ziekenhuis

    Arnhem,
    Netherlands

    Active - Recruiting

  • Rijnstate Ziekenhuis

    Arnhem,
    Netherlands

    Active - Recruiting

  • Amphia Ziekenhuis

    Breda,
    Netherlands

    Active - Recruiting

  • Martini Ziekenhuis

    Groningen,
    Netherlands

    Active - Recruiting

  • Tergooi Ziekenhuis

    Hilversum,
    Netherlands

    Active - Recruiting

  • St Antonius Ziekenhuis

    Nieuwegein,
    Netherlands

    Active - Recruiting

  • Franciscus Gasthuis en Vlietland

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Isala Klinieken

    Zwolle,
    Netherlands

    Active - Recruiting

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