Acute admission with bronchiolitis in infants = 6 weeks and = 12 months of age Respiratory Acute bronchiolitis
Conditions
Interventions
To test whether acceptance of lower oxygen saturation limits influences recovery from acute bronchiolitis, randomisation will be to a standard or modified pulse oximeter.
Standard oximeters will mea
a measured range of SpO2 85-90% will display as a range of SpO2 85-94%.
Sponsors
The University of Edinburgh and NHS Lothian (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Infants = 6 weeks and = 12 months of age, admitted to hospital with a clinical diagnosis of bronchiolitis made by a medically qualified practitioner in a emergency department (ED)/AAA
Exclusion criteria
Exclusion criteria: 1. Preterm (< 37 weeks gestation) who received home oxygen therapy in the past 4 weeks 2. Haemodynamically significant congenital heart disease 3. Cystic fibrosis or Interstitial lung disease 4. Documented immune function defect
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from randomisation to resolution of cough. For this outcome measure, we will be testing for equivalence between the two arms of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| For these outcome measures, we will be testing for difference between the two arms of the trial 1. Time from randomisation to 1.1. Fit for discharge 1.2. Actual discharge for all infants admitted with acute viral bronchiolitis (ward based data) 2. Proportion of infants with healthcare re-attendance (primary care, emergency department, readmission) (parental phone calls) 3. Change in parental anxiety score between admission and 28 days post admission (home visit questionnaire) 4. Time to return to work/usual activities for parent(s) post admission (parental phone call) 5. Time to return to nursery for infant post admission (parental phone call) 6. Family costs incurred related to time to return to work/nursery (demographic questionnaire and parental phone call) 7. Societal costs for parental return to work (demographic questionnaire and parental phone call) 8. Healthcare costs related to discharge time and subsequent healthcare utilisation (ward based data and parental phone calls) For these outcome measures, we will be testing for equivalence between the two arms of the trial 1. Time from randomisation to re-established feeding (approximately 75% normal) (nursing observation). Accept equivalence of 20% variance, consider as 4 hours based on previous data 2. Time from randomisation to parental perspective of back to normal (feeding, sleeping and asymptomatic) (parental phone call). Accept equivalence of 2 days, based on responses of clinicians to cough resolution times 3. Awake oxygen saturation at 28 days post randomisation (home visit). Accept equivalence of 1.0% SpO2, based on studies demonstrating healthy infant oxygen saturation | — |
Countries
United Kingdom
Outcome results
None listed