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

Bronchiolitis Clinical Trial

— OxyKids  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06016244
• Other study ID #: 2022.0100
• Secondary ID: 2023-504817-56
• Status: Recruiting
• Phase: N/A
• Start date: September 4, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Spaarne Gasthuis
• Contact: Sam Louman, MD
• Phone: +3123-2241645
• Email: slouman[@]spaarnegasthuis.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Weeks to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bronchial Hyperreactivity
• Bronchiolitis
• Lower Respiratory Tract Infection
• Respiratory Tract Infections

Intervention

Other:
• Oxygen saturation threshold
Oxygen saturation threshold on which supplemental oxygen is decided

Locations

Country	Name	City	State
Netherlands	Canisius Wilhelmina Ziekenhuis	Arnhem
Netherlands	Rijnstate Ziekenhuis	Arnhem
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Martini Ziekenhuis	Groningen
Netherlands	Spaarne Gasthuis	Haarlem	Noord-Holland
Netherlands	Tergooi Ziekenhuis	Hilversum
Netherlands	St Antonius Ziekenhuis	Nieuwegein
Netherlands	Franciscus Gasthuis en Vlietland	Rotterdam
Netherlands	Isala Klinieken	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
Spaarne Gasthuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Skin type influence	Investigation in to the influence of skin type on safety and effectiveness outcomes	Up to 90 days after discharge
Other	Time spent in 88%-92% window	Time spent in 88%-92% saturation window, measured by extracted continous monitoring data from patients where this is technically a possibility.	recorded at discharge based on monitoring data registered during admission, generally a few days to a week but longer if admission lasts longer.
Primary	Time to meeting all discharge criteria	Time in hours from admission 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.
Secondary	Length of stay	Time from admission to discharge in hours	During admission
Secondary	Pediatric Intensive Care Unit (PICU) admissions	Number of PICU admissions per group	During admission
Secondary	Time on oxygen therapy	Time in hours spent on supplemental oxygen	During admission
Secondary	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.	from admission to 90 days after discharge
Secondary	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	from admission to 90 days after discharge
Secondary	Time to return to school/daycare	Measured as days from admission to parent reported return to school/daycare	from admission to 90 days after discharge
Secondary	Unscheduled health care visits or admissions after discharge	Number of unscheduled visits or admissions up to 28 days after discharge	from admission to 28 days after discharge
Secondary	Patient quality of life	Measured by digital questionnaire of EQ-5D-Y (modified versions are used in agreement with EuroQol for patients < 4 years)	at discharge, 7, 28 and 90 days follow-up
Secondary	Overall pediatric health	ICHOM PROMIS Pediatric Global Health set	at discharge, 7, 28 and 90 days follow-up
Secondary	Parental anxiety	by anxiety items of Hospital Anxiety and Depression Scale	at discharge, 7 and 28 days follow-up
Secondary	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	Up to 90 days after discharge