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Not yet recruiting NCT06737159

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

Observational Bronchiolitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Bronchiolitis. Basic parameters: 5 Weeks — 24 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Utility of Severity Scales in Clinical Practice in Children Hospitalized Due to Bronchiolitis: Prospective Multicentre Cohort Study.

Overview

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.

Primary outcome measures

  • 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]
  • The time until the infant will be assessed as being 'fit for discharge' [Time frame: From admission to hospital discharge up to 2 weeks]
  • Worsening of clinical status, including the following [Time frame: From admission to hospital discharge up to 2 weeks]
  • Adverse events, especially incidence of pneumonia [Time frame: From admission to hospital discharge up to 2 weeks]
  • Hospital length of stay [Time frame: From admission to hospital discharge up to 2 weeks]

Eligibility criteria

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:
  • 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.

Exclusion criteria

1\. Diagnosis or suspicion of asthma.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Poland · 1 center
  • Szpital im. Św. Jadwigi Śląskiej — Trzebnica

Identifiers

NCT: NCT06737159 · 4/PNDR/2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗