Utility of Severity Scales in Clinical Practice in Children Hospitalized Due to Bronchiolitis: Prospective Multicentre Cohort Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Number of participants requiring oxygen supplementation
Study Overview
Brief Summary
Prospective observational study of patients hospitalized with bronchiolitis. The objective of our study is to compare the accuracy of commonly used clinical scales for bronchiolitis to predict relevant outcomes.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 5 Weeks to 24 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children eligible for the trial must fulfil all of the following criteria:
- •Children admitted to the hospital with the clinical diagnosis of acute bronchiolitis, which is defined as an apparent viral respiratory tract infection associated with airway obstruction manifested by at least one of following symptoms:
- •Tachypnoea (WHO definition).
- •Increased respiratory effort manifested as follows:
- •Nasal flaring;
- •Use of accessory muscles;
- •Intercostal and/or subcostal chest wall retractions;
- •Crackles and/or wheezing.
- •Aged 5 weeks - 24 months old.
Exclusion Criteria
- •Diagnosis or suspicion of asthma.
Outcomes
Primary Outcomes
Number of participants requiring oxygen supplementation
Time Frame: From admission to hospital discharge up to 2 weeks
Duration of oxygen supplementation
Time Frame: From admission to hospital discharge up to 2 weeks
among those requiring oxygen
The time until the infant will be assessed as being 'fit for discharge'
Time Frame: From admission to hospital discharge up to 2 weeks
which is defined as the point at which the infant will be feeding adequately (taking \>75% of their usual intake based on parents' assessment) and will have a saturation of at least 92% for 6 h on room air, while the axillary body temperature will remain
Worsening of clinical status, including the following
Time Frame: From admission to hospital discharge up to 2 weeks
PICU admission
Adverse events, especially incidence of pneumonia
Time Frame: From admission to hospital discharge up to 2 weeks
which is defined as: * temperature increase (fever \>38 ) * deterioration of general condition * inflammatory changes in lung ultrasound or chest X-ray
Hospital length of stay
Time Frame: From admission to hospital discharge up to 2 weeks
(\> 3 days)
Secondary Outcomes
No secondary outcomes reported