Skip to main content
MedPathMedPath Home
Clinical Trials/2023-504817-56-00
2023-504817-56-00
Active, not recruiting
Phase 4

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

Spaarne Gasthuis10 sites in 1 country560 target enrollmentStarted: June 27, 2023Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
Phase 4
Status
Active, not recruiting
Enrollment
560
Locations
10
Primary Endpoint
the time from admission to meeting all discharge criteria
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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%.

Eligibility Criteria

Ages
0 years to 17 years (0-17 Years)
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

the time from admission to meeting all discharge criteria

the time from admission to meeting all discharge criteria

Secondary Outcomes

  • Length of stay
  • Number of PICU admissions
  • Time spent on oxygen therapy
  • Duration of symptoms
  • Time from admission to return to normal health
  • Time from admission to return to school/day care
  • Unscheduled health care visits after discharge during follow-up
  • Patient Quality of Life
  • Parental anxiety
  • Overall pediatric health
  • Economic evaluation
  • Reasons for starting oxygen therapy

Investigators

Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Annemie L. M. Boehmer

Scientific

Spaarne Gasthuis

Study Sites (10)

Loading locations...

Similar Trials

Recruiting
Phase 1
Safe, effective and cost-effective oxygen saturation targets for children and adolescents with respiratory distress: a randomized controlled trial.Bronchiolitis, Viral wheeze / bronchial hyperreactivity, Lower respiratory tract infectionTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
CTIS2023-504817-56-00Spaarne Gasthuis560
Recruiting
Not Applicable
Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled TrialBronchiolitisLower Respiratory Tract InfectionBronchial Hyperreactivity
NCT06016244Spaarne Gasthuis560
Completed
Phase 4
Comparison of targeted treatment based on measuring oxygenation by central venous access versus usual care in children with septic shock
CTRI/2018/10/016169PGIMER264
Completed
Not Applicable
Extracorporeal Membrane Oxygenation in children - a retrospective data analysisTerminal heart and/or lung failure
DRKS00031027niversitätsklinikum Freiburg184
Not yet recruiting
Phase 3
Comparison of Low vs high oxygen saturation in PICU patients
CTRI/2023/11/060105Shubham Verma400