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

Not yet recruiting

• Conditions: Bronchiolitis

• Registration Number: NCT06737159
• Lead Sponsor: Szpital im. Św. Jadwigi Śląskiej

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-27
• Status Verified: 2024-12
• Study Start: 2024-12
• Study First Submitted QC: 2024-12-11
• Last Update Submitted: 2024-12-11
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Szpital im. Św. Jadwigi Śląskiej; 🇵🇱 Trzebnica, Poland