Safe, effective and cost-effective oxygen saturation targets for children and adolescents with respiratory distress: a randomized controlled trial.

Phase 1

Recruiting

Conditions: Bronchiolitis, Viral wheeze / bronchial hyperreactivity, Lower respiratory tract infection
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: CTIS2023-504817-56-00

Lead Sponsor: Spaarne Gasthuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 560

Inclusion Criteria

Children aged 6 weeks to 12 years, Hospitalized with lower respiratory distress due to bronchiolitis, viral wheeze or lower respiratory tract infection, Requiring supplemental oxygen (SpO2 <92% or otherwise indicated by the treating physician)

Exclusion Criteria

children with other pre-existing respiratory diseases, cardiovascular, neurological or hematological conditions, children born <32 weeks gestational age, previously included in the study, considering questionnaires are only available in Dutch and English, children (of parents) with different languages will be excluded., children (of parents) without a stable internet connection needed for answering questionnaires, children already included in other studies, which potentially interfere with this study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective: to investigate if an SpO2 threshold of 88% for children and adolescents admitted with respiratory distress results in a safe reduction of length of hospital stay, compared to an SpO2 threshold of 92%.;Secondary Objective: To investigate if an SpO2 threshold of 88% leads to differences in duration and severity of symptoms, readmissions, time to normal activity, patient and parent quality of life and cost-effectiveness compared to an SpO2 threshold of 92%.;Primary end point(s): the time from admission to meeting all discharge criteria

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Length of stay;Secondary end point(s):Number of PICU admissions;Secondary end point(s):Time spent on oxygen therapy;Secondary end point(s):Duration of symptoms;Secondary end point(s):Time from admission to return to normal health;Secondary end point(s):Time from admission to return to school/day care;Secondary end point(s):Unscheduled health care visits after discharge during follow-up;Secondary end point(s):Patient Quality of Life;Secondary end point(s):Parental anxiety;Secondary end point(s):Overall pediatric health;Secondary end point(s):Economic evaluation;Secondary end point(s):Reasons for starting oxygen therapy