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Starting soon Observational

Utility of Severity Scales in Clinical Practice in Children Hospitalized Due to Bronchiolitis.

NCT06737159 · tracked via the Priya Life Science Poland tracker
Sponsor
Szpital im. Św. Jadwigi Śląskiej
Phase
Observational
Started
2024-12
Last updated
2024-12-17

Condition(s) studied

Bronchiolitis

Study 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.

Eligibility

Sex
ALL
Min age
5 Weeks
Max age
24 Months
Healthy volunteers
No
Inclusion Criteria: Children eligible for the trial must fulfil all of the following criteria: 1\. 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: 1. Nasal flaring; 2. Grunting; 3. Use of accessory muscles; 4. Intercostal and/or subcostal chest wall retractions; 5. Apnoe. * Crackles and/or wheezing. 2. Aged 5 weeks - 24 months old. Exclusion Criteria: 1\. Diagnosis or suspicion of asthma.

Primary outcome measure(s)

  • Number of participants requiring oxygen supplementation — From admission to hospital discharge up to 2 weeks
  • Duration of oxygen supplementation — 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' — 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 — From admission to hospital discharge up to 2 weeks
    PICU admission
  • Adverse events, especially incidence of pneumonia — 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 — From admission to hospital discharge up to 2 weeks
    (\> 3 days)

Trial sites (1)

FacilityCityRegionStatus
Szpital im. Św. Jadwigi Śląskiej Trzebnica Poland
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06737159 on ClinicalTrials.gov ↗ ← All trials in Poland