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Completed
NCT06016244
Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial
Conditions: Bronchiolitis, Lower Respiratory Tract Infection, Bronchial Hyperreactivity
Sex: All
Ages: 6 Weeks – 12 Years
Healthy volunteers: No
Phase: NA
Enrollment: 566
Sponsor: Spaarne Gasthuis
Location: Spaarne Gasthuis Haarlem North Holland
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 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 \
Source: ClinicalTrials.gov (NCT06016244). StuddyBuddy aggregates publicly available trial information.