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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02093715
Other study ID # TASMC-13-YS-07-075-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received March 19, 2014
Last updated August 31, 2014
Start date July 2007

Study information

Verified date June 2014
Source Tel-Aviv Sourasky Medical Center
Contact Yakov Sivan, Professor
Email sivan@tlvmc.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational [Patient Registry]

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date
Est. primary completion date August 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 2 Years
Eligibility Inclusion Criteria:

- First episode of shortness of breath

- Children in ages 2 weeks to 2 years

Exclusion Criteria:

- Any chronic disease

- Congenital anomalies

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Sourasky Medical Center Tel-Aviv

Sponsors (1)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Other Wheezing episode From recruitment time till the age 4. No
Other PCR for respiratory viruses 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. At recruitment No
Primary Physician diagnosed asthma Modification of The International Study of Asthma and Allergies in Childhood (ISAAC) questionnaires At the age of 4 years No
Secondary Fractional exhaled Nitric Oxide (FENO) level FeNO level measured by a rapid-response chemiluminescence analyzer (Eco Physics CLD88 NO analyzer, EcoMedics AG,Switzerland). During acute bronchiolitis, after 2 and 6 months No
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