Childhood Measures of NICU-based Chemical Exposure

Withdrawn

• Conditions: Development

• Registration Number: NCT02292680
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-11-12
• Study First Submitted QC: 2014-11-12
• Study First Posted: 2014-11-17
• Study Start: 2017-01
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-06
• Last Update Posted: 2017-11-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chemical Concentration in deciduous teeth	up to 5 years	Teeth will be analyzed by a dentist and researcher trained in laser ablation inductively coupled plasma mass spectroscopy technology

Secondary Outcome Measures

Name	Time	Method
Wechsler Preschool and Primary Scale of Intelligence	up to 3 years	Developmental Outcomes measured using this assessments
Child Behavior Checklist	up to 3 years	An assessment Developmental Outcomes measured using this assessments
Development Neuropsychological Assessment (NEPSY)	up to 3 years	Developmental Outcomes measured using this assessments