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NCT00342758 · ClinicalTrials.gov registry record
Early Life Factors and Respiratory Health in Mexico City Children
A clinical trial of Respiratory Ilness, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- Completed
- Registry status
- 6,800
- Enrollment target
- 4
- Study locations
NCT00342758: Completed study of Respiratory Ilness, sponsored by National Institute of Environmental Health Sciences (NIEHS).
NCT00342758 is a study of Respiratory Ilness that has completed, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 6,800 participants. The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00342758, a study of Respiratory Ilness, has completed, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- COMPLETED
- Registry status
- 6,800 participants
- Enrollment target
- 4
- Study locations
Study Summary
Early life exposures now appear to be important in modulation of the immune response and tendency to develop asthma. We plan to enroll a cohort of children at birth to study early life factors in the development of wheezing and respiratory illness during the first six years of life in Mexico City. In particular, we will consider the role of early diet (particularly antioxidant intake, lactation and obesity), infections, dust mite and cockroach antigens, traffic related air pollution, and environmental tobacco smoke. We will also consider the potential modifying effect of genetic predisposition with respect to the exposures of interest. Approximately 6,800 children will be enrolled at birth. The goal is to follow the cohort though age 6. To increase the number of expected cases of asthma, we will partially enrich the cohort for increased risk of asthma by virtue of having a parent with doctor diagnosis of asthma or allergies; the remaining cohort will not be enriched to preserve generalizability. Pregnant women enrolled in a prepaid health plan in Mexico City (the Insituto Mexicano de Seguridad Social, henceforth referred to as IMSS) will be screened for the study and invited to enrolled their newborns when they come for delivery at one of two IMSS hospitals. An initial home visit during the first three months of life will include assessment of environmental exposures and infant diet. Children will be followed through age six with yearly home visits, monitoring of acute lower respiratory illness during the first year of life and periodic review of the IMSS medical records. We have chosen Mexico City because of the relatively low rates of asthma in the face of prevalent exposures to factors that are thought to increase asthma risk in urban areas in the United States. These include dust mites, cockroach, airborne pollutants and social factors such as low income and young maternal age. This pattern suggests that protective factors may be operating in Mexico City that
Conditions Studied
Study Locations (4)
Other
- Hospital Infantil de Mexico Federico Gomez - Mexico City
- Instituto Mexicano del Seguro Social - Mexico City
- National Institute of Public Health - Mexico City
North Carolina
- NIEHS, Research Triangle Park - Research Triangle Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,800 participants |
| Start Date | 2001-10-01 |
| Est. Completion | 2007-10-15 |
What the finished NCT00342758 record still lists
NCT00342758 is an observational study that tracks outcomes without assigning an intervention. Its 6,800 participants enrollment target places it among the larger protocols in the corpus.
The record links to 1 condition, with Respiratory Ilness appearing as the primary indexed condition, and to 0 interventions.
NCT00342758 reports a single indexed study location in Other, North Carolina.
Frequently Asked Questions
What is clinical trial NCT00342758 about?
NCT00342758 is a clinical study titled "Early Life Factors and Respiratory Health in Mexico City Children". Early life exposures now appear to be important in modulation of the immune response and tendency to develop asthma. We plan to enroll a cohort of children at birth to study early life factors in the development of wheezing and respiratory illness during the first six years of life in Mexico City. I...
What is the current status of trial NCT00342758?
This trial is currently completed. The enrollment target is 6,800 participants. The study started on 2001-10-01. Estimated completion is 2007-10-15.
What conditions does trial NCT00342758 study?
This clinical trial studies the following conditions: Respiratory Ilness.
Who is sponsoring clinical trial NCT00342758?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00342758 being conducted?
This trial has 4 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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