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

This study is currently recruiting participants.
Verified June 2014 by Tel-Aviv Sourasky Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02093715
First Posted: March 21, 2014
Last Update Posted: September 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
  Purpose
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
Acute Bronchiolitis

Study Type: Observational [Patient Registry]
Study Design: 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

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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:
  • 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:
  • Wheezing episode [ Time Frame: From recruitment time till the age 4. ]
  • 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

Estimated Enrollment: 400
Study Start Date: July 2007
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

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 Submitted: March 19, 2014
First Posted: March 21, 2014
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