BronchiolitisNCT06737159
Utility of Severity Scales in Clinical Practice in Children Hospitalized Due to Bronchiolitis.
An observational study of Bronchiolitis, run by Szpital im. Św. Jadwigi Śląskiej at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 weeks to 24 months
- Conditions the study is for
- Bronchiolitis
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- Dec 2024to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 weeks to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: Hospitalized patients with diagnosis of bronchiolitis
Who may be able to join
- 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;
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- Use of accessory muscles;
- Intercostal and/or subcostal chest wall retractions;
- Apnoe.
- Crackles and/or wheezing. 2. Aged 5 weeks - 24 months old.
Who cannot join
- 1. Diagnosis or suspicion of asthma.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Szpital im. Św. Jadwigi Śląskiej
Trzebnica, 55-100
Henryk Szymański, MD, PhD, 0048604467073, henryk.t.szymanski@gmail.com
Aleksandra Buczek, MD
About this study
Official title: Utility of Severity Scales in Clinical Practice in Children Hospitalized Due to Bronchiolitis: Prospective Multicentre Cohort Study.
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
- Medical subject headings
- Bronchiolitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants requiring oxygen supplementation
Measured: From admission to hospital discharge up to 2 weeks
Duration of oxygen supplementation
among those requiring oxygen
Measured: 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
Measured: From admission to hospital discharge up to 2 weeks
Worsening of clinical status, including the following
PICU admission
Measured: 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
Measured: From admission to hospital discharge up to 2 weeks
Hospital length of stay
(> 3 days)
Measured: From admission to hospital discharge up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szpital im. Św. Jadwigi Śląskiej
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737159
- Sponsor's protocol ID
- 4/PNDR/2023
- Status last verified
- Dec 2024
- First submitted
- 27 Nov 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or generated during this study will be made available after the publication of results
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Severity Scales in Clinical Practice in Children Hospitalized Due to Bronchiolitis: Prospective Multicentre Cohort Study.
- ClinicalTrials.gov ID
- NCT06737159
- Acronym / sponsor ID
- 4/PNDR/2023
- Conditions
- Bronchiolitis
- Keywords
- bronchiolitis, bronchiolitis severity scoring, validation, utility
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Szpital im. Św. Jadwigi ŚląskiejUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 weeks to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Hospitalized patients with diagnosis of bronchiolitis
Key inclusion criteria (10 listed)
- 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:
- Crackles and/or wheezing. 2. Aged 5 weeks - 24 months old.
Key exclusion criteria (1 listed)
- 1. Diagnosis or suspicion of asthma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
among those requiring oxygen
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
Worsening of clinical status, including the following
Time frame: From admission to hospital discharge up to 2 weeks
PICU admission
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
Hospital length of stay
Time frame: From admission to hospital discharge up to 2 weeks
(> 3 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: Yes. The datasets used and/or generated during this study will be made available after the publication of results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiolitis, run by Szpital im. Św. Jadwigi Śląskiej at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henryk Szymański MD PhD (0048604467073, henryk.t.szymanski@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants requiring oxygen supplementation (time frame: From admission to hospital discharge up to 2 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.