Bronchial Hyperreactivity, Bronchiolitis, Lower Respiratory Tract Infection
Conditions
Keywords
Oxygen saturation target, SpO2, Children
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?
Interventions
OTHEROxygen saturation threshold
Oxygen saturation threshold on which supplemental oxygen is decided
Sponsors
Spaarne Gasthuis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled trial, parallel group, block randomized and stratified by age and centre.
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Discharge criteria include: * No need for supplemental oxygen for 4 hours, including a period of sleep for children aged \< 2 years * Clinically fit for discharge with normal or minimally increased respiratory rate AND no or mild respiratory distress, as judged by nurses and physicians using the Parshuram et al scoring system, commonly used in Dutch paediatric practice as part of the Pediatric Early Warning Scale\]. * No need for in-hospital feeding or medication by nasogastric tube (NGT). * No need for in-hospital intravenous treatment. * No need for in-hospital nebulized bronchodilator treatment. * No need for in-hospital treatment with metered dose inhalator inhalations more often than every 3 hours. * No need for high flow delivered by high flow nasal cannula or nasal prongs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATORAnnmeie LM Boehmer, MD, PhD
Spaarne Gasthuis
Outcome results
None listed