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

Acute Bronchiolitis Clinical Trial

Official title:

FeNO and Cytokines in RSV and Non RSV Bronchiolitis in Relation to Future Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02093715
• Other study ID #: TASMC-13-YS-07-075-CTIL
• 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. 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

• Acute Bronchiolitis
• Bronchiolitis

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