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

Sponsor

Spaarne Gasthuis (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06016244

Collaborator

(none)

560

Enrollment

Locations

Arms

27.9

Anticipated Duration (Months)

62.2

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

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?

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis Lower Respiratory Tract Infection Bronchial Hyperreactivity	Other: Oxygen saturation threshold	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

560 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trial, parallel group, block randomized and stratified by age and centre.Randomized controlled trial, parallel group, block randomized and stratified by age and centre.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 4, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: Oxygen saturation threshold Oxygen saturation threshold on which supplemental oxygen is decided
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.	Other: Oxygen saturation threshold Oxygen saturation threshold on which supplemental oxygen is decided

Arm

Intervention/Treatment

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.

Other: Oxygen saturation threshold

Oxygen saturation threshold on which supplemental oxygen is decided

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.

Other: Oxygen saturation threshold

Oxygen saturation threshold on which supplemental oxygen is decided

Outcome Measures

Primary Outcome Measures

Time to meeting all discharge criteria [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.]
Time in hours from admission to meeting all discharge criteria

Secondary Outcome Measures

Length of stay [During admission]
Time from admission to discharge in hours
Pediatric Intensive Care Unit (PICU) admissions [During admission]
Number of PICU admissions per group
Time on oxygen therapy [During admission]
Time in hours spent on supplemental oxygen
Duration of symptoms [from admission to 90 days after discharge]
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 [from admission to 90 days after discharge]
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 [from admission to 90 days after discharge]
Measured as days from admission to parent reported return to school/daycare
Unscheduled health care visits or admissions after discharge [from admission to 28 days after discharge]
Number of unscheduled visits or admissions up to 28 days after discharge
Patient quality of life [at discharge, 7, 28 and 90 days follow-up]
Measured by digital questionnaire of EQ-5D-Y (modified versions are used in agreement with EuroQol for patients < 4 years)
Overall pediatric health [at discharge, 7, 28 and 90 days follow-up]
ICHOM PROMIS Pediatric Global Health set
Parental anxiety [at discharge, 7 and 28 days follow-up]
by anxiety items of Hospital Anxiety and Depression Scale
Economic evaluation [Up to 90 days after discharge]
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

Other Outcome Measures

Skin type influence [Up to 90 days after discharge]
Investigation in to the influence of skin type on safety and effectiveness outcomes
Time spent in 88%-92% window [recorded at discharge based on monitoring data registered during admission, generally a few days to a week but longer if admission lasts longer.]
Time spent in 88%-92% saturation window, measured by extracted continous monitoring data from patients where this is technically a possibility.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Weeks to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Spaarne Gasthuis	Haarlem	Noord-Holland	Netherlands	2035 RC
2	Canisius Wilhelmina Ziekenhuis	Arnhem		Netherlands
3	Rijnstate Ziekenhuis	Arnhem		Netherlands
4	Amphia Ziekenhuis	Breda		Netherlands
5	Martini Ziekenhuis	Groningen		Netherlands
6	Tergooi Ziekenhuis	Hilversum		Netherlands
7	St Antonius Ziekenhuis	Nieuwegein		Netherlands
8	Franciscus Gasthuis en Vlietland	Rotterdam		Netherlands
9	Isala Klinieken	Zwolle		Netherlands