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Antibiotics in Infancy--Risk Factor for Childhood Asthma

Primary Purpose

Asthma, Lung Diseases

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
Augusta University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Asthma

Eligibility Criteria

undefined - 7 Years (Child)All SexesDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 20, 2002
    Last Updated
    December 21, 2015
    Sponsor
    Augusta University
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00037726
    Brief Title
    Antibiotics in Infancy--Risk Factor for Childhood Asthma
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    December 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 2004 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Augusta University
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma, Lung Diseases

    7. Study Design

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dennis Ownby
    Organizational Affiliation
    Augusta University

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12762090
    Citation
    Johnson CC, Ownby DR, Zoratti EM, Alford SH, Williams LK, Joseph CL. Environmental epidemiology of pediatric asthma and allergy. Epidemiol Rev. 2002;24(2):154-75. doi: 10.1093/epirev/mxf013. No abstract available.
    Results Reference
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    PubMed Identifier
    14767444
    Citation
    Williams LK, Peterson EL, Ownby DR, Johnson CC. The relationship between early fever and allergic sensitization at age 6 to 7 years. J Allergy Clin Immunol. 2004 Feb;113(2):291-6. doi: 10.1016/j.jaci.2003.11.010.
    Results Reference
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    PubMed Identifier
    15536408
    Citation
    Alford SH, Zoratti E, Peterson EL, Maliarik M, Ownby DR, Johnson CC. Parental history of atopic disease: disease pattern and risk of pediatric atopy in offspring. J Allergy Clin Immunol. 2004 Nov;114(5):1046-50. doi: 10.1016/j.jaci.2004.08.036.
    Results Reference
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    PubMed Identifier
    14612678
    Citation
    Ownby DR, Johnson CC. Does exposure to dogs and cats in the first year of life influence the development of allergic sensitization? Curr Opin Allergy Clin Immunol. 2003 Dec;3(6):517-22. doi: 10.1097/00130832-200312000-00015.
    Results Reference
    background
    PubMed Identifier
    15940137
    Citation
    Johnson CC, Ownby DR, Alford SH, Havstad SL, Williams LK, Zoratti EM, Peterson EL, Joseph CL. Antibiotic exposure in early infancy and risk for childhood atopy. J Allergy Clin Immunol. 2005 Jun;115(6):1218-24. doi: 10.1016/j.jaci.2005.04.020.
    Results Reference
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    Antibiotics in Infancy--Risk Factor for Childhood Asthma

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