Childhood Measures of NICU-based Chemical Exposure

Novel Biomarkers for Exposures in the Neonatal Intensive Care Unit

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.

Study Overview

• Status: Withdrawn
• Conditions: 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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Annemarie Stroustrup, MD,MPH, Ichan School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2017
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: November 12, 2014
• First Submitted That Met QC Criteria: November 12, 2014
• First Posted (Estimate): November 17, 2014

Study Record Updates

• Last Update Posted (Actual): November 8, 2017
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: neurodevelopmental outcomes; dentin; environmental exposures
• Other Study ID Numbers: GCO 14-1403