Acute BronchiolitisNCT02093715
FeNO and Cytokines in Respiratory Syncytial Virus (RSV) and Non RSV Bronchiolitis in Relation to Future Asthma
An observational study of Acute Bronchiolitis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine Fractional exhaled Nitric-Oxide (FeNO)levels and blood cytokines during acute bronchiolitis, and to seek for correlation between these markers and future development of asthma. Read more about this study
- Who is it for?
- Ages 2 weeks to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Bronchiolitis
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2007to Aug 2020
- How long will I take part?
- 7 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 2 weeks to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children ages 2 weeks to 2 years who will arrive to Dana Children's hospital, Tel-Aviv Medical Center due to first episode of shortness of breath and working diagnosis of bronchiolitis.
Who may be able to join
- First episode of shortness of breath
- Children in ages 2 weeks to 2 years
Who cannot join
- Any chronic disease
- Congenital anomalies
Trial locations and contacts
1 site in 1 country.
Yakov Sivan, Professor contact
About this study
Official title: FeNO and Cytokines in RSV and Non RSV Bronchiolitis in Relation to Future Asthma
The purpose of this study is to determine Fractional exhaled Nitric-Oxide (FeNO)levels and blood cytokines during acute bronchiolitis, and to seek for correlation between these markers and future development of asthma.
- Conditions
- Acute Bronchiolitis
- Keywords
- Bronchiolitis, FeNO, Asthma, wheezing, RSV
- Medical subject headings
- Bronchiolitis, Asthma, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RSV | Infant with acute bronchiolitis due to RSV | |
| Co- Infection | Infant with acute bronchiolitis due to RSV and other respiratory virus | |
| Other | Infant with acute bronchiolitis due to non-RSV respiratory virus | |
| Unknown | Infant with acute bronchiolitis with negative PCR results for respiratory viruses | |
| Control | Healthy infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician diagnosed asthma
Modification of The International Study of Asthma and Allergies in Childhood (ISAAC) questionnaires
Measured: At the age of 4 years
Secondary outcomes (1)
Fractional exhaled Nitric Oxide (FENO) level
FeNO level measured by a rapid-response chemiluminescence analyzer (Eco Physics CLD88 NO analyzer, EcoMedics AG,Switzerland).
Measured: During acute bronchiolitis, after 2 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startJul 2007
- Primary completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute BronchiolitisStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- 400 participants (estimated)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093715
- Sponsor's protocol ID
- TASMC-13-YS-07-075-CTIL
- Status last verified
- Jun 2014
- First submitted
- 19 Mar 2014
- Last updated
- 3 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FeNO and Cytokines in RSV and Non RSV Bronchiolitis in Relation to Future Asthma
- ClinicalTrials.gov ID
- NCT02093715
- Acronym / sponsor ID
- TASMC-13-YS-07-075-CTIL
- Conditions
- Acute Bronchiolitis
- Keywords
- Bronchiolitis, FeNO, Asthma, wheezing, RSV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jul 2007
- Primary completion
- Aug 2020 (estimated)
- First posted
- 21 Mar 2014 (estimated)
- 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.
The purpose of this study is to determine Fractional exhaled Nitric-Oxide (FeNO)levels and blood cytokines during acute bronchiolitis, and to seek for correlation between these markers and future development of asthma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| RSV | – | –Infant with acute bronchiolitis due to RSV |
| Co- Infection | – | –Infant with acute bronchiolitis due to RSV and other respiratory virus |
| Other | – | –Infant with acute bronchiolitis due to non-RSV respiratory virus |
| Unknown | – | –Infant with acute bronchiolitis with negative PCR results for respiratory viruses |
| Control | – | –Healthy infants |
Who may qualify
- Ages
- 2 weeks to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children ages 2 weeks to 2 years who will arrive to Dana Children's hospital, Tel-Aviv Medical Center due to first episode of shortness of breath and working diagnosis of bronchiolitis.
Key inclusion criteria (2 listed)
- First episode of shortness of breath
- Children in ages 2 weeks to 2 years
Key exclusion criteria (2 listed)
- Any chronic disease
- Congenital anomalies
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
Physician diagnosed asthma
Time frame: At the age of 4 years
Modification of The International Study of Asthma and Allergies in Childhood (ISAAC) questionnaires
1 secondary outcome
Fractional exhaled Nitric Oxide (FENO) level
Time frame: During acute bronchiolitis, after 2 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
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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. This study is not recruiting at the moment.
Yakov Sivan, Professor contact
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 Acute Bronchiolitis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 3 Sep 2014. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yakov Sivan, Professor (sivan@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician diagnosed asthma (time frame: At the age of 4 years). 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 3 Sep 2014.