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Not yet recruitingNCT06737159Updated Dec 17, 2024

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

An observational study in Bronchiolitis, sponsored by Szpital im. Św. Jadwigi Śląskiej. Not yet recruiting at 1 site in Poland. Open to participants aged 5 Weeks to 24 Months. Per ClinicalTrials.gov, last updated 2024-12-17.

Sponsored by Szpital im. Św. Jadwigi Śląskiej · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 8 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
5 Weeks to 24 Months
Sex
All
01

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.

02

Conditions studied

  • Bronchiolitis

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Keywords

  • bronchiolitis
  • bronchiolitis severity scoring
  • validation
  • utility
03

In context

Bronchiolitis

289 studies on the registry are indexed under Bronchiolitis; 51 are open to participants now.

This study's planned enrollment of 150 is below the median of 200 across 79 observational studies indexed under Bronchiolitis.

Browse Bronchiolitis studies →

Lead sponsor

Szpital im. Św. Jadwigi Śląskiej is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Weeks to 24 Months
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hospitalized patients with diagnosis of bronchiolitis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Diagnosis or suspicion of asthma.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No
06

What researchers measure

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

    among those requiring oxygen

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

  3. 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

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

  4. Worsening of clinical status, including the following

    PICU admission

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

  5. 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

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

  6. Hospital length of stay

    (\> 3 days)

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

07

Study locations

1 site
  • Szpital im. Św. Jadwigi Śląskiej
    Trzebnica, 55-100, Poland
08

References and documents

Individual participant data

Plan to share: Yes — The datasets used and/or generated during this study will be made available after the publication of results

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: Avaliable after the publication

Access criteria: Upon researcher's personal request

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2024; primary completion for Mar 2026, 15 months later.

Of 26 observational studies under Bronchiolitis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 87. This study's planned 15 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 27, 2024
First posted
Dec 17, 2024
StartEst.
Dec 2024
Primary completionEst.
Mar 2026
CompletionEst.
Mar 2026
Last update
Dec 17, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06737159
Lead sponsor
Szpital im. Św. Jadwigi Śląskiej
Responsible party
Sponsor
First posted
Dec 17, 2024
Start date
Dec 2024 (estimated)
Primary completion
Mar 2026 (estimated)
Completion
Mar 2026 (estimated)
Last update
Dec 17, 2024

Study contacts

Henryk Szymański MD PhD
Contact
henryk.t.szymanski@gmail.com
0048604467073

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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