BronchiolitisNCT01684527
Immature Myeloid Cells in Respiratory Syncytial Virus Bronchioliltis
An observational study of Bronchiolitis, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The investigators hypothesize that Respiratory Syncytial Virus (RSV) infection may influence the population of lung immature myeloid cells and dendritic cells in a way that will impair their ability to invoke an effective immune response and lead to prolonged inflammation, angiogenesis and scarring. Read more about this study
- Who is it for?
- Ages Up to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Respiratory secretions obtained
- How many people
- 55 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2012to Jan 2014
- 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 Up to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children presenting in our pediatric department suffering from bronchiolitis
Who may be able to join
- Bronchiolitis
Who cannot join
- Chronic disease
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Vered Nir, MD, 972-4-630-4331, verednr@yahoo.com
Vered Nir, MD
About this study
The investigators hypothesize that Respiratory Syncytial Virus (RSV) infection may influence the population of lung immature myeloid cells and dendritic cells in a way that will impair their ability to invoke an effective immune response and lead to prolonged inflammation, angiogenesis and scarring. This may lead in turn to disturbed lung function.
Our aim is to determine the presence and phenotype of immature myeloid cells present in respiratory secretions of children with RSV bronchiolitis as compared to non-RSV bronchiolitis and healthy controls.
- Conditions
- Bronchiolitis
- Being tested
- Respiratory secretions obtained
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory secretions obtainedOther
| Study group | Role | What they receive |
|---|---|---|
| Children Suffering From Bronchiolitis | Respiratory secretions obtained from children suffering from Bronchiolitis Receives: Other: Respiratory secretions obtained | |
| Healthy Children | Respiratory secretions obtained from children with no respiratory infection Receives: Other: Respiratory secretions obtained |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Immature Myeloid Cells in Respiratory Secretions
Respiratory secretions obtained from child presenting with bronchiolitis will be examined for the presence of immature myeloid cells
Measured: Participants will be followed for the duration of hospital stay, an expected average of one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684527
- Sponsor's protocol ID
- 0039-12-HYMC
- Status last verified
- Sep 2012
- First submitted
- 5 Sep 2012
- Last updated
- 13 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immature Myeloid Cells in Respiratory Syncytial Virus Bronchioliltis
- ClinicalTrials.gov ID
- NCT01684527
- Acronym / sponsor ID
- 0039-12-HYMC
- Conditions
- Bronchiolitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Oct 2012
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 13 Sep 2012 (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 investigators hypothesize that Respiratory Syncytial Virus (RSV) infection may influence the population of lung immature myeloid cells and dendritic cells in a way that will impair their ability to invoke an effective immune response and lead to prolonged inflammation, angiogenesis and scarring. This may lead in turn to disturbed lung function.
Our aim is to determine the presence and phenotype of immature myeloid cells present in respiratory secretions of children with RSV bronchiolitis as compared to non-RSV bronchiolitis and healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children Suffering From Bronchiolitis | – | Other: Respiratory secretions obtainedRespiratory secretions obtained from children suffering from Bronchiolitis |
| Healthy Children | – | Other: Respiratory secretions obtainedRespiratory secretions obtained from children with no respiratory infection |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children presenting in our pediatric department suffering from bronchiolitis
Key inclusion criteria (1 listed)
- Bronchiolitis
Key exclusion criteria (1 listed)
- Chronic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory secretions obtained | Other | Children Suffering From Bronchiolitis, Healthy Children |
Primary outcome
Number of Immature Myeloid Cells in Respiratory Secretions
Time frame: Participants will be followed for the duration of hospital stay, an expected average of one week
Respiratory secretions obtained from child presenting with bronchiolitis will be examined for the presence of immature myeloid cells
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2012.
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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.
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 Hillel Yaffe 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 1 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: status not confirmed, as of the sponsor's last update on 13 Sep 2012. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Immature Myeloid Cells in Respiratory Secretions (time frame: Participants will be followed for the duration of hospital stay, an expected average of one week). 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 13 Sep 2012.