Antibiotics in Infancy--Risk Factor for Childhood Asthma
Primary Purpose
Asthma, Lung Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Asthma
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00037726
First Posted
May 20, 2002
Last Updated
December 21, 2015
Sponsor
Augusta University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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
background
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
background
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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