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Risk of Asthma in Infants With Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00459576
Recruitment Status : Completed
First Posted : April 12, 2007
Last Update Posted : April 17, 2013
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )

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.

Condition or disease
Asthma Eczema Dermatitis, Atopic

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.

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk of Asthma in Infants With Atopic Dermatitis
Study Start Date : May 2005
Actual Primary Completion Date : January 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Eczema

Biospecimen Retention:   Samples With DNA
We have retained nasal cell samples, whole blood cells, and serum.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 7 Years   (Child)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00459576

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United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
National Institutes of Health (NIH)
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Principal Investigator: Robert S Tepper, MD, PhD Indiana University
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Responsible Party: Indiana University School of Medicine Identifier: NCT00459576    
Other Study ID Numbers: 0211-15
First Posted: April 12, 2007    Key Record Dates
Last Update Posted: April 17, 2013
Last Verified: April 2013
Keywords provided by Indiana University ( Indiana University School of Medicine ):
Dermatitis, Atopic
Additional relevant MeSH terms:
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Dermatitis, Atopic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous