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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 12
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Canisius Wilhelmina Ziekenhuis
RECRUITING
Arnhem
Rijnstate Ziekenhuis
RECRUITING
Arnhem
Amphia Ziekenhuis
RECRUITING
Breda
Martini Ziekenhuis
RECRUITING
Groningen
Spaarne Gasthuis
RECRUITING
Haarlem
Tergooi Ziekenhuis
RECRUITING
Hilversum
St Antonius Ziekenhuis
RECRUITING
Nieuwegein
Franciscus Gasthuis en Vlietland
RECRUITING
Rotterdam
Isala Klinieken
RECRUITING
Zwolle
Contact Information
Primary
Sam Louman, MD
slouman@spaarnegasthuis.nl
+3123-2241645
Time Frame
Start Date: 2023-09-04
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 560
Treatments
Experimental: 88% oxygen saturation threshold
Patients in this arm will receive supplemental oxygen when SpO2 falls below 88% or when other clinical symptoms indicate a need for supplemental oxygen.
Active_comparator: 92% oxygen saturation threshold
Patients in this arm will receive supplemental oxygen when SpO2 falls below 92% or when other clinical symptoms indicate a need for supplemental oxygen.
Related Therapeutic Areas
Sponsors
Leads: Spaarne Gasthuis

This content was sourced from clinicaltrials.gov