Risk of Asthma in Infants With Atopic Dermatitis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00459576
First received: April 11, 2007
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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.


Condition
Asthma
Eczema
Dermatitis, Atopic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk of Asthma in Infants With Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Indiana University:

Biospecimen Retention:   Samples With DNA

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


Enrollment: 120
Study Start Date: May 2005
Study Completion Date: December 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Asthma is a disease characterized by recurrent episodes of wheezing, inflammation of the airways, and airways that are very sensitive to stimulation (hyper-responsiveness). Symptoms of asthma frequently begin in early childhood; however, it has been difficult to identify pre-symptomatic, at-risk infants and toddlers. Family history of asthma and allergy is strongly associated with the early onset and persistence of asthma symptoms, and children with early onset persistent asthma are more likely to demonstrate allergies. The development of allergic disease results from complex interactions between genetic susceptibility and environmental factors; however, infants with atopic dermatitis have a 50% chance of developing asthma by 6 years of age. Airway inflammation and airway hyper-responsiveness are characteristics of asthmatic children. We plan to evaluate whether infants with allergic dermatitis have evidence of airway inflammation and hyper-responsiveness, and whether cells from the blood and the nose are also hyper-responsive to stimulation prior to the onset of clinical symptoms of asthma. In addition we will evaluate whether certain genetic profiles are associated with allergic disease in infants.

  Eligibility

Ages Eligible for Study:   2 Months to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.

Criteria

Inclusion criteria-

  1. Full term infants born greater than 37 weeks
  2. History of atopic dermatitis or eczema

Exclusion criteria

  1. Heart disease
  2. asthma
  3. Respiratory illness such as RSV, bronchiolitis or croup
  4. Hospitalization for respiratory illness
  5. History of wheezing
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459576

Locations
United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: Robert S Tepper, MD, PhD Indiana University
  More Information

No publications provided

Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00459576     History of Changes
Other Study ID Numbers: 0211-15
Study First Received: April 11, 2007
Last Updated: April 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Asthma
Eczema
Dermatitis, Atopic
Infant

Additional relevant MeSH terms:
Asthma
Dermatitis
Dermatitis, Atopic
Bronchial Diseases
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on October 23, 2014