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Early Life Factors and Respiratory Health in Mexico City Children
NCT00342758 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00342758
The ClinicalTrials.gov registry entry for NCT00342758 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 6,800 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Environmental Health Sciences (NIEHS), which has 75 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Respiratory Ilness appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00342758 reports 4 study locations spanning 2 distinct geographic areas — top geographies include Other, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT00342758?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 75 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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