Back to resultsSafe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial (OxyKids)
Primary Purpose
Bronchiolitis, Lower Respiratory Tract Infection, Bronchial Hyperreactivity
Status
Not yet recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Oxygen saturation threshold
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis focused on measuring Oxygen saturation target, SpO2, Children
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: children with, except for the studied diseases, pre-existing cardiopulmonary, neurological or hematological conditions (e.g. congenital thoracic malformation, airway malacia, post infectious bronchiolitis obliterans, childhood interstitial lung disease. primary immune deficiency) children born <32 weeks gestational age children already included in other studies, which potentially interfere with this study children (of parents) without a stable internet connection needed for answering questionnaires children previously included in the current study considering questionnaires are only available in Dutch and English, children (of parents) with different languages will be excluded.
Sites / Locations
- Spaarne Gasthuis
- Canisius Wilhelmina Ziekenhuis
- Rijnstate Ziekenhuis
- Amphia Ziekenhuis
- Martini Ziekenhuis
- Tergooi Ziekenhuis
- St Antonius Ziekenhuis
- Franciscus Gasthuis en Vlietland
- Isala Klinieken
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
88% oxygen saturation threshold
92% oxygen saturation threshold
Arm Description
Patients in this arm will receive supplemental oxygen when SpO2 falls below 88% or when other clinical symptoms indicate a need for supplemental oxygen.
Patients in this arm will receive supplemental oxygen when SpO2 falls below 92% or when other clinical symptoms indicate a need for supplemental oxygen.
Outcomes
Primary Outcome Measures
Time to meeting all discharge criteria
Time in hours from admission to meeting all discharge criteria
Secondary Outcome Measures
Length of stay
Time from admission to discharge in hours
Pediatric Intensive Care Unit (PICU) admissions
Number of PICU admissions per group
Time on oxygen therapy
Time in hours spent on supplemental oxygen
Duration of symptoms
Measured as days from admission to having met all of the following criteria: resolution of cough, resolution of dyspnea as indicated by parent, cessation of scheduled bronchodilator use.
Return to normal health
Measured as days from admission to parent reported normal health. Upon discharge parents/patients are asked to record the last day of illness and report this in the follow-up questionnaires
Time to return to school/daycare
Measured as days from admission to parent reported return to school/daycare
Unscheduled health care visits or admissions after discharge
Number of unscheduled visits or admissions up to 28 days after discharge
Patient quality of life
Measured by digital questionnaire of EQ-5D-Y (modified versions are used in agreement with EuroQol for patients < 4 years)
Overall pediatric health
ICHOM PROMIS Pediatric Global Health set
Parental anxiety
by anxiety items of Hospital Anxiety and Depression Scale
Economic evaluation
The aim of the economic evaluation is to relate the incremental costs of an SpO2 of 88% (intervention) in comparison with an SpO2 of 92% (control) to the incremental health effects. Both a cost-effectiveness analysis (CEA) and a cost-utility analysis (CUA) will be performed from a societal and healthcare perspective
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06016244
Brief Title
Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial
Acronym
OxyKids
Official Title
Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 4, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spaarne Gasthuis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis, Lower Respiratory Tract Infection, Bronchial Hyperreactivity
Keywords
Oxygen saturation target, SpO2, Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial, parallel group, block randomized and stratified by age and centre.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
560 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
88% oxygen saturation threshold
Arm Type
Experimental
Arm Description
Patients in this arm will receive supplemental oxygen when SpO2 falls below 88% or when other clinical symptoms indicate a need for supplemental oxygen.
Arm Title
92% oxygen saturation threshold
Arm Type
Active Comparator
Arm Description
Patients in this arm will receive supplemental oxygen when SpO2 falls below 92% or when other clinical symptoms indicate a need for supplemental oxygen.
Intervention Type
Other
Intervention Name(s)
Oxygen saturation threshold
Intervention Description
Oxygen saturation threshold on which supplemental oxygen is decided
Primary Outcome Measure Information:
Title
Time to meeting all discharge criteria
Description
Time in hours from admission to meeting all discharge criteria
Time Frame
Discharge criteria are checked daily during admission up to discharge (generally a few days up to a week but longer if admission lasts longer) and the time and date at which all discharge criteria have been met will be recorded.
Secondary Outcome Measure Information:
Title
Length of stay
Description
Time from admission to discharge in hours
Time Frame
During admission
Title
Pediatric Intensive Care Unit (PICU) admissions
Description
Number of PICU admissions per group
Time Frame
During admission
Title
Time on oxygen therapy
Description
Time in hours spent on supplemental oxygen
Time Frame
During admission
Title
Duration of symptoms
Description
Measured as days from admission to having met all of the following criteria: resolution of cough, resolution of dyspnea as indicated by parent, cessation of scheduled bronchodilator use.
Time Frame
from admission to 90 days after discharge
Title
Return to normal health
Description
Measured as days from admission to parent reported normal health. Upon discharge parents/patients are asked to record the last day of illness and report this in the follow-up questionnaires
Time Frame
from admission to 90 days after discharge
Title
Time to return to school/daycare
Description
Measured as days from admission to parent reported return to school/daycare
Time Frame
from admission to 90 days after discharge
Title
Unscheduled health care visits or admissions after discharge
Description
Number of unscheduled visits or admissions up to 28 days after discharge
Time Frame
from admission to 28 days after discharge
Title
Patient quality of life
Description
Measured by digital questionnaire of EQ-5D-Y (modified versions are used in agreement with EuroQol for patients < 4 years)
Time Frame
at discharge, 7, 28 and 90 days follow-up
Title
Overall pediatric health
Description
ICHOM PROMIS Pediatric Global Health set
Time Frame
at discharge, 7, 28 and 90 days follow-up
Title
Parental anxiety
Description
by anxiety items of Hospital Anxiety and Depression Scale
Time Frame
at discharge, 7 and 28 days follow-up
Title
Economic evaluation
Description
The aim of the economic evaluation is to relate the incremental costs of an SpO2 of 88% (intervention) in comparison with an SpO2 of 92% (control) to the incremental health effects. Both a cost-effectiveness analysis (CEA) and a cost-utility analysis (CUA) will be performed from a societal and healthcare perspective
Time Frame
Up to 90 days after discharge
Other Pre-specified Outcome Measures:
Title
Skin type influence
Description
Investigation in to the influence of skin type on safety and effectiveness outcomes
Time Frame
Up to 90 days after discharge
Title
Time spent in 88%-92% window
Description
Time spent in 88%-92% saturation window, measured by extracted continous monitoring data from patients where this is technically a possibility.
Time Frame
recorded at discharge based on monitoring data registered during admission, generally a few days to a week but longer if admission lasts longer.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
children with, except for the studied diseases, pre-existing cardiopulmonary, neurological or hematological conditions (e.g. congenital thoracic malformation, airway malacia, post infectious bronchiolitis obliterans, childhood interstitial lung disease. primary immune deficiency)
children born <32 weeks gestational age
children already included in other studies, which potentially interfere with this study
children (of parents) without a stable internet connection needed for answering questionnaires
children previously included in the current study
considering questionnaires are only available in Dutch and English, children (of parents) with different languages will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sam Louman, MD
Phone
+3123-2241645
Email
slouman@spaarnegasthuis.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annmeie LM Boehmer, MD, PhD
Organizational Affiliation
Spaarne Gasthuis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaarne Gasthuis
City
Haarlem
State/Province
Noord-Holland
ZIP/Postal Code
2035 RC
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annemie LM Boehmer, MD, PhD
Phone
+31232240070
Email
aboehmer@spaarnegasthuis.nl
First Name & Middle Initial & Last Name & Degree
Sam Louman, MD
Phone
+31232241645
Email
slouman@spaarnegasthuis.nl
First Name & Middle Initial & Last Name & Degree
Annemie LM Boehmer, MD, PhD
Facility Name
Canisius Wilhelmina Ziekenhuis
City
Arnhem
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianne L Brouwer
Phone
+31243658146
Email
m.l.brouwer@cwz.nl
First Name & Middle Initial & Last Name & Degree
Marianne L Brouwer
Facility Name
Rijnstate Ziekenhuis
City
Arnhem
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mirjam Scheffer
Phone
+31880057782
Email
mscheffer@rijnstate.nl
First Name & Middle Initial & Last Name & Degree
Mirjam Scheffer
Facility Name
Amphia Ziekenhuis
City
Breda
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anja Vaessen-Verberne
Phone
+31765951012
Email
avaessen-verberne@amphia.nl
First Name & Middle Initial & Last Name & Degree
Anja Vaessen-Verberne
Facility Name
Martini Ziekenhuis
City
Groningen
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arvid Kamps
Phone
+31505245245
Email
akamps@martini.nl
First Name & Middle Initial & Last Name & Degree
Arvid Kamps
Facility Name
Tergooi Ziekenhuis
City
Hilversum
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Kosterink-Brackel
Phone
+31887531160
Email
ckosterinkbrackel@tergooi.nl
First Name & Middle Initial & Last Name & Degree
Caroline Kosterink-Brackel
Facility Name
St Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walter Balemans
Phone
+31883206300
Email
w.balemans@antoniusziekenhuis.nl
First Name & Middle Initial & Last Name & Degree
Walter Balemans
Facility Name
Franciscus Gasthuis en Vlietland
City
Rotterdam
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ismé de Kleer
Phone
+31104616225
Email
i.kleer@franciscus.nl
First Name & Middle Initial & Last Name & Degree
Ismé de Kleer
Facility Name
Isala Klinieken
City
Zwolle
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jolita Bekhof
Phone
+31886245050
Email
j.bekhof@isala.nl
First Name & Middle Initial & Last Name & Degree
Jolita Bekhof
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data and metadata will be made available for reuse after removing data from participants who did not consent to reuse of their data and removing any potentially identifiable data. Data archiving and sharing will be done through DANS EASY. The Dublin Core metadata scheme will be used.
IPD Sharing Time Frame
The data will only be made available for reuse after completion of the study and all planned publications of the results.
IPD Sharing Access Criteria
Other researchers will be able to find the metadata in the data repository. They could express their interest in the dataset through emailing the PI. After meeting the sharing and reuse conditions and approval of the PI, data access will be provided through the data repository.
Learn more about this trial
Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial
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