NCT02292680

Brief Summary

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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Status
withdrawn

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

First Submitted

Initial submission to the registry

November 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
2.1 years until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

November 8, 2017

Status Verified

November 1, 2017

Enrollment Period

6 months

First QC Date

November 12, 2014

Last Update Submit

November 6, 2017

Conditions

Development

Keywords

dentinenvironmental exposuresneurodevelopmental outcomes

Outcome Measures

Primary Outcomes (1)

  • Chemical Concentration in deciduous teeth

    Teeth will be analyzed by a dentist and researcher trained in laser ablation inductively coupled plasma mass spectroscopy technology

    up to 5 years

Secondary Outcomes (3)

  • Child Behavior Checklist

    up to 3 years

  • Wechsler Preschool and Primary Scale of Intelligence

    up to 3 years

  • Development Neuropsychological Assessment (NEPSY)

    up to 3 years

Study Arms (1)

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.

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children who were cared for as neonates in the Mount Sinai NICU

You may qualify if:

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

You may not qualify if:

  • Parent documented in Mount Sinai's database is no longer the legal guardian
  • Non-English-speaking parents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Annemarie Stroustrup, MD,MPH

    Ichan School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 17, 2014

Study Start

January 1, 2017

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

November 8, 2017

Record last verified: 2017-11