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

NCT06737159 | Not Yet Recruiting

• 1 other identifier: 4/PNDR/2023
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis

Keywords

bronchiolitis; bronchiolitis severity scoring; validation; utility

Outcome Measures

Primary Outcomes (6)

• Number of participants requiring oxygen supplementation

  From admission to hospital discharge up to 2 weeks

• Duration of oxygen supplementation

  among those requiring oxygen

  From admission to hospital discharge up to 2 weeks

• The time until the infant will be assessed as being 'fit for discharge'

  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

  From admission to hospital discharge up to 2 weeks

• Worsening of clinical status, including the following

  PICU admission

  From admission to hospital discharge up to 2 weeks

• Adverse events, especially incidence of pneumonia

  which is defined as: * temperature increase (fever \>38 ) * deterioration of general condition * inflammatory changes in lung ultrasound or chest X-ray

  From admission to hospital discharge up to 2 weeks

• Hospital length of stay

  (\> 3 days)

  From admission to hospital discharge up to 2 weeks

Eligibility Criteria

• Age: 5 Weeks - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients with diagnosis of bronchiolitis

You may qualify if:

• 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;
• Grunting;
• Use of accessory muscles;
• Intercostal and/or subcostal chest wall retractions;
• Apnoe.
• Crackles and/or wheezing. 2. Aged 5 weeks - 24 months old.

You may not qualify if:

• \. Diagnosis or suspicion of asthma.

Sponsors & Collaborators

• Szpital im. Św. Jadwigi Śląskiej: lead

Study Sites (1)

Szpital im. Św. Jadwigi Śląskiej

Trzebnica, 55-100, Poland

Location

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Central Study Contacts

Henryk Szymański MD PhD

CONTACT

0048604467073; henryk.t.szymanski@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 17, 2024
• Study Start: December 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Avaliable after the publication
• Access Criteria: Upon researcher's personal request

Locations

PL (1)