Trials / Withdrawn
WithdrawnNCT02292680
Childhood Measures of NICU-based Chemical Exposure
Novel Biomarkers for Exposures in the Neonatal Intensive Care Unit
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Icahn School of Medicine at Mount Sinai · Academic / Other
- Sex
- All
- Age
- 4 Years – 6 Years
- Healthy volunteers
- Accepted
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.
Conditions
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2017-07-01
- Completion
- 2017-07-01
- First posted
- 2014-11-17
- Last updated
- 2017-11-08
Source: ClinicalTrials.gov record NCT02292680. Inclusion in this directory is not an endorsement.