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CompletedNCT00037726Updated Dec 23, 2015

Antibiotics in Infancy--Risk Factor for Childhood Asthma

An observational study in Asthma and Lung Diseases, sponsored by Augusta University. Completed. Open to participants aged Up to 7 Years. Per ClinicalTrials.gov, last updated 2015-12-23.

Sponsored by Augusta University · Observational

Study type
Observational
Ages
Up to 7 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Asthma
  • Lung Diseases
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In context

Asthma

3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.

Browse Asthma studies →

Lead sponsor

Augusta University is the lead sponsor of 177 studies on the registry; 24 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

No eligibility criteria

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Study design

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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 12762090 ↗
  • 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. PubMed 14767444 ↗
  • 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. PubMed 15536408 ↗
  • 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. PubMed 14612678 ↗
  • 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. PubMed 15940137 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00037726
Lead sponsor
Augusta University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
First posted
May 21, 2002
Start date
Apr 2001
Completion
Mar 2004
Last update
Dec 23, 2015

Study contacts

Dennis Ownby
Augusta University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2005. You cannot join it, but the record below documents what was studied.

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