- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005427
Cohort Study of Respiratory Illness in Early Childhood
Study Overview
Status
Conditions
Detailed Description
BACKGROUND:
The study built on a previous study funded by the Health Effects Institute, a non-profit foundation jointly supported by the U.S. Environmental Protection Agency and vehicle manufacturers. The previous study was a prospective cohort study of nitrogen dioxide (NO2) exposure and respiratory symptoms and illnesses during the first 18 months of life. Between January, 1988 and June, 1990, 1,315 infants were enrolled and then followed with collection of daily respiratory symptom data and serial monitoring of NO2 concentrations in their homes. The full protocol was completed by 823 subjects and a total follow-up experience of over one-half million days was accumulated. Follow-up ended in December, 1991 and analyses related to the study's principal focus, the health effects of NO2, was completed during the fall of 1992.
DESIGN NARRATIVE:
The analyses were directed at the following: 1) Time spent in day-care and the incidence and severity of respiratory illnesses; 2) Breast-feeding and the incidence and severity of respiratory illnesses during the first six months of life; 3) Determinants of wheezing and wheezing illnesses; 4) Determinants of a physician-diagnosis of asthma; 5) Exposure to woodsmoke and incidence and severity of respiratory illnesses; 6) Household demographics, including ethnicity, and incidence and severity of respiratory illnesses; 7) Determinants of the duration of respiratory illnesses; 8) The validity of retrospective parental reports of respiratory illness; 9) Parental perceptions of the risks of indoor and outdoor air pollution; 10) Clinical findings on assessment of ill children in the community.
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Bosken CH, Hunt WC, Lambert WE, Samet JM. A parental history of asthma is a risk factor for wheezing and nonwheezing respiratory illnesses in infants younger than 18 months of age. Am J Respir Crit Care Med. 2000 Jun;161(6):1810-5. doi: 10.1164/ajrccm.161.6.9903030.
- Cushing AH, Samet JM, Lambert WE, Skipper BJ, Hunt WC, Young SA, McLaren LC. Breastfeeding reduces risk of respiratory illness in infants. Am J Epidemiol. 1998 May 1;147(9):863-70. doi: 10.1093/oxfordjournals.aje.a009540.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4345
- R03HL049896 (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.
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