Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037726
Status:
COMPLETED
Last Update Posted:
2015-12-23
First Post:
2002-05-20
Brief Title:
Antibiotics in Infancy--Risk Factor for Childhood Asthma
Sponsor:
Augusta University
Organization:
Augusta University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 67 years of age At 67 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
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 67 years of age At 67 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R03HL067427 | NIH | None | httpsreporternihgovquickSearchR03HL067427 |