NCT00011674

Brief Summary

This prospective cohort study examines the role of prenatal and early postnatal lead exposure on the neuropsychological status and social adjustment of adolescents enrolled in the Cincinnati Lead Study. We are examining the relationship between moderate exposure to lead and neuropsychological deficits, difficulties in peer relationships, personality disturbances and juvenile delinquency. This birth cohort of approximately 300 subjects has been followed since 1980 with regularly scheduled assessments of blood lead concentrations, health history, social and hereditary factors, and neurobehavioral development.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 1997

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1997

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2001

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2001

Completed
Last Updated

March 23, 2006

Status Verified

March 1, 2006

First QC Date

February 26, 2001

Last Update Submit

March 22, 2006

Conditions

Lead Poisoning

Keywords

LeadPrenatalDevelopmentChildrenPsychologyToxicologyTeratology

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Subjects for the Cincinnati Lead Study were recruited prenatally if their mothers resided in areas within Cincinnati, Ohio where there has historically been a high incidence of lead poisoning. Infants were eligible for follow-up if they were greater than 1500 grams at birth and had no disqualifying medical conditions such as defined genetic syndromes or other serious complications that may adversely affect neurobehavioral development.

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Sponsors & Collaborators

Study Sites (1)

Findlay Street Clinic

Cincinnati, Ohio, 45214, United States

Location

MeSH Terms

Conditions

Lead Poisoning

Condition Hierarchy (Ancestors)

Heavy Metal PoisoningPoisoningChemically-Induced Disorders

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

February 26, 2001

First Posted

February 28, 2001

Study Start

May 1, 1997

Study Completion

May 1, 2001

Last Updated

March 23, 2006

Record last verified: 2006-03

Locations

US(1)