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FeNO and Cytokines in Respiratory Syncytial Virus (RSV) and Non RSV Bronchiolitis in Relation to Future Asthma

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ClinicalTrials.gov Identifier: NCT02093715
Recruitment Status : Recruiting
First Posted : March 21, 2014
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Brief 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.

Condition or disease
Acute Bronchiolitis

Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 7 Years
Official Title: FeNO and Cytokines in RSV and Non RSV Bronchiolitis in Relation to Future Asthma
Study Start Date : July 2007
Estimated Primary Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Group/Cohort
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



Primary Outcome Measures :
  1. Physician diagnosed asthma [ Time Frame: At the age of 4 years ]
    Modification of The International Study of Asthma and Allergies in Childhood (ISAAC) questionnaires


Secondary Outcome Measures :
  1. Fractional exhaled Nitric Oxide (FENO) level [ Time Frame: During acute bronchiolitis, after 2 and 6 months ]
    FeNO level measured by a rapid-response chemiluminescence analyzer (Eco Physics CLD88 NO analyzer, EcoMedics AG,Switzerland).


Other Outcome Measures:
  1. Wheezing episode [ Time Frame: From recruitment time till the age 4. ]
  2. PCR for respiratory viruses [ Time Frame: At recruitment ]
    Polymerase chain reaction (PCR) analysis of nasal secretion for: RSV, Influenza A, Influenza B, Pandemic H1N1, Adenovirus, human metapneumovirus (hMPV), Parainfluenza 1-3, Enterovirus, Bocavirus, Rhinovirus, Corona virus-229E, Corona-OC43, Corona-HKU1 and Corona-NL63.


Biospecimen Retention:   Samples Without DNA
blood


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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • First episode of shortness of breath
  • Children in ages 2 weeks to 2 years

Exclusion Criteria:

  • Any chronic disease
  • Congenital anomalies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02093715


Contacts
Contact: Yakov Sivan, Professor sivan@tlvmc.gov.il

Locations
Israel
Sourasky Medical Center Recruiting
Tel-Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02093715     History of Changes
Other Study ID Numbers: TASMC-13-YS-07-075-CTIL
First Posted: March 21, 2014    Key Record Dates
Last Update Posted: September 3, 2014
Last Verified: June 2014

Keywords provided by Tel-Aviv Sourasky Medical Center:
Bronchiolitis
FeNO
Asthma
wheezing, RSV

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections