Status:
RECRUITING
Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial
Lead Sponsor:
Spaarne Gasthuis
Conditions:
Bronchiolitis
Lower Respiratory Tract Infection
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief 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 br...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
560 Patients enrolled
Trial Details
Trial ID
NCT06016244
Start Date
September 4 2023
End Date
December 31 2025
Last Update
October 16 2024
Active Locations (9)
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1
Spaarne Gasthuis
Haarlem, North Holland, Netherlands, 2035 RC
2
Canisius Wilhelmina Ziekenhuis
Arnhem, Netherlands
3
Rijnstate Ziekenhuis
Arnhem, Netherlands
4
Amphia Ziekenhuis
Breda, Netherlands