Childhood Measures of NICU-based Chemical Exposure | NCT02292680

Studies
Childhood Measures of NICU-based Chemical Exposure

NCT02292680

Sponsor

Icahn School of Medicine at Mount Sinai

Status

Withdrawn

Last Update Posted

Nov 8, 2017Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Development

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to enroll

Expanded Access Info

Start Date

Jan 2017Estimated

Primary Completion Date

Jul 2017Actual

Completion Date

Jul 2017Actual

First Submitted Date

Nov 12, 2014

First Submission Date that Met QC Criteria

Nov 12, 2014

First Posted Date

Nov 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2017

Last Update Posted Date

Nov 8, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Annemarie Stroustrup, MD,MPH	Ichan School of Medicine at Mount Sinai	Principal Investigator

Locations

Not provided