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

NCT06016244 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2024-10-16

No results posted yet for this 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?

Conditions

  • Bronchiolitis
  • Lower Respiratory Tract Infection
  • Bronchial Hyperreactivity

Interventions

OTHER

Oxygen saturation threshold

Oxygen saturation threshold on which supplemental oxygen is decided

Sponsors & Collaborators

  • Spaarne Gasthuis

    lead OTHER

Principal Investigators

  • Annmeie LM Boehmer, MD, PhD · Spaarne Gasthuis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-04
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06016244 on ClinicalTrials.gov