- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00037726
Antibiotics in Infancy--Risk Factor for Childhood Asthma
Study Overview
Status
Conditions
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.
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Dennis Ownby, Augusta University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1174
- R03HL067427 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lung Diseases
-
Aveiro UniversityFundação para a Ciência e a TecnologiaNot yet recruitingInterstitial Lung DiseasesPortugal
-
RWTH Aachen UniversityCompletedObstructive Lung DiseasesGermany
-
Guangzhou Institute of Respiratory DiseaseUnknownInterstitial Lung Disease | Transbronchial Lung Cryobiopsy | Surgical Lung Biopsy
-
China-Japan Friendship HospitalXiangya Hospital of Central South University; Peking Union Medical College... and other collaboratorsUnknown
-
Academisch Medisch Centrum - Universiteit van Amsterdam...CompletedInterstitial Lung DiseasesNetherlands
-
Centre Hospitalier Universitaire de Saint EtienneCompleted
-
Bastiaan DriehuysNational Heart, Lung, and Blood Institute (NHLBI); University of Iowa; Children... and other collaboratorsRecruitingInterstitial Lung DiseasesUnited States
-
Shanghai East HospitalRegend TherapeuticsCompletedInterstitial Lung DiseasesChina
-
Aveiro UniversityFundação para a Ciência e a Tecnologia; Centro Hospitalar do Baixo VougaRecruitingInterstitial Lung Diseases (ILD)Portugal
-
China-Japan Friendship HospitalNot yet recruitingTransbronchial Lung Cryobiopsy