Childhood Measures of NICU-based Chemical Exposure

NCT ID: NCT02292680

Last Updated: 2017-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-07-31

Brief Summary

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This study aims to identify early life exposures to metals and chemicals by measuring the concentration of metals and organic compounds in shed primary teeth. The researchers will also investigate associations between the presence of these chemicals in teeth and children's social, emotional, and neuro-development.

Detailed Description

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Since children begin shedding their primary teeth around age 6, the investigators will enroll children who will be turning 6 in the next two years. First, the investigators will follow up with the children's development by conducting a battery of non-invasive neurodevelopmental tests. Also, the parents will be asked to complete a questionnaire called the Child Behavior Checklist, which assesses behavioral problems. Then, each child's parent will be asked to send the research team 2-3 teeth that their child has shed, or to send teeth as they are shed over the next three years. Dr. Stroustrup's collaborator, Dr. Manish Arora, will perform a temporal analysis of chemical distribution for each tooth to determine each child's environmental exposures during the perinatal and neonatal periods.

Conditions

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Development

Keywords

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dentin environmental exposures neurodevelopmental outcomes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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NICU Tooth Study Cohort

All study subjects will have been cared for in the Mount Sinai NICU and have had the same hospital environment exposure.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 4-6 years of age in 2014 (six years of age by the end of 2016)
* Cared for as a neonate in Mount Sinai's NICU

Exclusion Criteria

* Parent documented in Mount Sinai's database is no longer the legal guardian
* Non-English-speaking parents
Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Annemarie Stroustrup, MD,MPH

Role: PRINCIPAL_INVESTIGATOR

Ichan School of Medicine at Mount Sinai

Countries

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United States

Other Identifiers

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GCO 14-1403

Identifier Type: -

Identifier Source: org_study_id