Clinical trial NCT06016244: Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial
Official title: Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bronchiolitis
Lower Respiratory Tract Infection
Bronchial Hyperreactivity
Keywords: Oxygen saturation target
SpO2
Children
Lead sponsor: Spaarne Gasthuis
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 560
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial, parallel group, block randomized and stratified by age and centre.
Primary purpose: TREATMENT

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?


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

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.

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.

Primary outcomes:
measure: Time to meeting all discharge criteria
timeFrame: 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 outcomes:
measure: Length of stay
timeFrame: During admission
measure: Pediatric Intensive Care Unit (PICU) admissions
timeFrame: During admission
measure: Time on oxygen therapy
timeFrame: During admission
measure: Duration of symptoms
timeFrame: from admission to 90 days after discharge
measure: Return to normal health
timeFrame: from admission to 90 days after discharge
measure: Time to return to school/daycare
timeFrame: from admission to 90 days after discharge
measure: Unscheduled health care visits or admissions after discharge
timeFrame: from admission to 28 days after discharge
measure: Patient quality of life
timeFrame: at discharge, 7, 28 and 90 days follow-up
measure: Overall pediatric health
timeFrame: at discharge, 7, 28 and 90 days follow-up
measure: Parental anxiety
timeFrame: at discharge, 7 and 28 days follow-up
measure: Economic evaluation
timeFrame: Up to 90 days after discharge
Other outcomes:
measure: Skin type influence
timeFrame: Up to 90 days after discharge
measure: Time spent in 88%-92% window
timeFrame: recorded at discharge based on monitoring data registered during admission, generally a few days to a week but longer if admission lasts longer.
Locations:
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
state: Noord-Holland
city: Arnhem
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Hilversum
country: Netherlands
facility: Tergooi Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St Antonius Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis en Vlietland
city: Zwolle
country: Netherlands
facility: Isala Klinieken
Study officials:
affiliation: Spaarne Gasthuis
name: Annmeie LM Boehmer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: