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NCT Number: NCT06737159

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

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.

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Key information

Conditions

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

Age range

5 week–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Szpital im. Św. Jadwigi Śląskiej

Trzebnica, 55-100, Poland

Location contact

Aleksandra Buczek, MD

CONTACT

Henryk Szymański, MD, PhD

CONTACT

[email protected]

0048604467073

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • 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

  • Diagnosis or suspicion of asthma.

Treatment and study plan

Primary outcomes

  1. Number of participants requiring oxygen supplementation

    Time frame: From admission to hospital discharge up to 2 weeks

  2. Duration of oxygen supplementation

    Time frame: From admission to hospital discharge up to 2 weeks

    among those requiring oxygen

  3. 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

  4. Worsening of clinical status, including the following

    Time frame: From admission to hospital discharge up to 2 weeks

    PICU admission

  5. 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

  6. Hospital length of stay

    Time frame: From admission to hospital discharge up to 2 weeks

    (> 3 days)

Study contacts

Contact information is provided by the study sponsor or research team.

Henryk Szymański MD PhD

CONTACT

[email protected]

0048604467073

Sponsors and collaborators

Lead sponsor

Szpital im. Św. Jadwigi Śląskiej

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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