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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 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.

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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

FieldValue
Enrollment Target 6,800 participants
Start Date 2001-10-01
Est. Completion 2007-10-15

What the Registry Record Tells You About NCT00342758

The ClinicalTrials.gov registry entry for NCT00342758 describes a study currently listed as completed, categorized as an unspecified phase. 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 145 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Respiratory Ilness appearing as the primary indexed condition, and to 0 interventions.

NCT00342758 reports 4 study locations spanning 2 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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