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Antibiotics in Infancy--Risk Factor for Childhood Asthma

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: NCT00037726
Recruitment Status : Completed
First Posted : May 21, 2002
Last Update Posted : December 23, 2015
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Augusta University

Brief Summary:
To examine possible relationships between antibiotic use, as determined by prescriptions filled, and asthma in children ages 6 to 7.

Condition or disease
Asthma Lung Diseases

Detailed Description:


Morbidity and mortality from childhood asthma have been increasing in all developed countries over the past three decades, including in the United States. Numerous theories have been advanced to explain this asthma epidemic, but no single theory has held up to careful scrutiny. Recent international studies have suggested a relatively strong causal relationship between increased risk of childhood asthma and exposure to antibiotics during childhood, especially during the first year of life. The increased asthma risk was seen whether antibiotics were used to treat respiratory or non-respiratory infections. While these previous studies are suggestive, there are significant methodologic concerns about each study. A major concern with most of the studies is their reliance on retrospective recall of antibiotic exposure data from parents years after the exposure. The study relied on prospective data from the Childhood Asthma Study.


Data were used from the prospective, NIH-funded study of the relationship between early environmental exposures and the development of asthma in a birth cohort of children followed to an average 6.7 years of age. At 6.7 years, 482 (58%) of the original 833 children were clinically examined as part of this Childhood Asthma Study (CAS). In addition to clinical histories, the 6- to 7- year clinical examination included skin tests, IgE antibody tests, pulmonary function tests and methacholine challenge. At entry all of the CAS children were within the Health Alliance Plan (HAP) HMO. The study was based on combining the CAS data set with pharmacy data extracted from the HAP data archives. This allowed an examination of possible relationships between antibiotic use, as determined by prescriptions filled, and asthma at 6 to 7 years of age. While not strictly a prospective study, these methods avoided many of the potential sources of bias found in previous studies. The study was also able to evaluate any relationships between antibiotic exposure and asthma for confounding by other risk factors such as bedroom allergen levels, pet ownership, cigarette smoke exposure, and parental history of asthma or allergy.

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Study Type : Observational
Study Start Date : April 2001
Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
No eligibility criteria

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): NCT00037726

Sponsors and Collaborators
Augusta University
National Heart, Lung, and Blood Institute (NHLBI)
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OverallOfficial: Dennis Ownby Augusta University

Layout table for additonal information Identifier: NCT00037726    
Other Study ID Numbers: 1174
R03HL067427 ( U.S. NIH Grant/Contract )
First Posted: May 21, 2002    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2005
Additional relevant MeSH terms:
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Lung Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases