NCT00459576

Brief Summary

Infants will be enrolled in this study if they have never been diagnosed with asthma or wheezing and have been diagnosed with atopic dermatitis or eczema. Infants with some types of skin rashes are at high risk for developing asthma by 6 years of age. The purpose of this study is to determine whether we can identify infants who will develop asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2007

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 17, 2013

Status Verified

April 1, 2013

Enrollment Period

6.7 years

First QC Date

April 11, 2007

Last Update Submit

April 16, 2013

Conditions

AsthmaEczemaDermatitis, Atopic

Keywords

AsthmaEczemaDermatitis, AtopicInfant

Eligibility Criteria

Age2 Months - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Our population was recruited through primary physician, pediatric practices, and dermatology groups through out Indianapolis Indiana and the surrounding counties. We also ran ads in local newspapers.

You may qualify if:

  • Full term infants born greater than 37 weeks
  • History of atopic dermatitis or eczema

You may not qualify if:

  • Heart disease
  • asthma
  • Respiratory illness such as RSV, bronchiolitis or croup
  • Hospitalization for respiratory illness
  • History of wheezing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

We have retained nasal cell samples, whole blood cells, and serum.

MeSH Terms

Conditions

AsthmaEczemaDermatitis, Atopic

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Robert S Tepper, MD, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2007

First Posted

April 12, 2007

Study Start

May 1, 2005

Primary Completion

January 1, 2012

Study Completion

December 1, 2012

Last Updated

April 17, 2013

Record last verified: 2013-04

Locations

US(1)