NCT06016244

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 560 (estimated)
• Sponsor: Spaarne Gasthuis · Academic / Other
• Sex: All
• Age: 6 Weeks – 12 Years
• Healthy volunteers: Not accepted

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?

Conditions

• Bronchiolitis
• Lower Respiratory Tract Infection
• Bronchial Hyperreactivity

Interventions

Type	Name	Description
OTHER	Oxygen saturation threshold	Oxygen saturation threshold on which supplemental oxygen is decided

Timeline

• Start date: 2023-09-04
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-08-29
• Last updated: 2024-10-16

Locations

9 sites across 1 country: Netherlands