NCT02093715

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Last Updated

September 3, 2014

Status Verified

June 1, 2014

Enrollment Period

13.1 years

First QC Date

March 19, 2014

Last Update Submit

August 31, 2014

Conditions

Acute Bronchiolitis

Keywords

BronchiolitisFeNOAsthmawheezing, RSV

Outcome Measures

Primary Outcomes (1)

  • Physician diagnosed asthma

    Modification of The International Study of Asthma and Allergies in Childhood (ISAAC) questionnaires

    At the age of 4 years

Secondary Outcomes (1)

  • Fractional exhaled Nitric Oxide (FENO) level

    During acute bronchiolitis, after 2 and 6 months

Other Outcomes (2)

  • Wheezing episode

    From recruitment time till the age 4.

  • PCR for respiratory viruses

    At recruitment

Study Arms (5)

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 Criteria

Age2 Weeks - 2 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Any chronic disease
  • Congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

BronchiolitisAsthmaRespiratory Sounds

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Yakov Sivan, Professor

CONTACT

sivan@tlvmc.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Years
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2014

First Posted

March 21, 2014

Study Start

July 1, 2007

Primary Completion

August 1, 2020

Last Updated

September 3, 2014

Record last verified: 2014-06

Locations

IL(1)