Childhood Measures of NICU-based Chemical Exposure

Development Clinical Trial

Official title:

Novel Biomarkers for Exposures in the Neonatal Intensive Care Unit

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02292680
• Other study ID #: GCO 14-1403
• Status: Withdrawn
• Phase: N/A
• First received: November 12, 2014
• Last updated: November 6, 2017
• Start date: January 2017
• Est. completion date: July 2017

Study information

• Verified date: November 2017
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Development

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Outcome

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