DevelopmentNCT02292680
Childhood Measures of NICU-based Chemical Exposure
An observational study of Development, run by Icahn School of Medicine at Mount Sinai.
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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Development
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children who were cared for as neonates in the Mount Sinai NICU
Who may be able to join
- 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
Who cannot join
- Parent documented in Mount Sinai's database is no longer the legal guardian
- Non-English-speaking parents
About this study
Official title: 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.
Read the 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
- Development
- Keywords
- dentin, environmental exposures, neurodevelopmental outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Chemical Concentration in deciduous teeth
Teeth will be analyzed by a dentist and researcher trained in laser ablation inductively coupled plasma mass spectroscopy technology
Measured: up to 5 years
Secondary outcomes (3)
Child Behavior Checklist
An assessment Developmental Outcomes measured using this assessments
Measured: up to 3 years
Wechsler Preschool and Primary Scale of Intelligence
Developmental Outcomes measured using this assessments
Measured: up to 3 years
Development Neuropsychological Assessment (NEPSY)
Developmental Outcomes measured using this assessments
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startJan 2017 (estimated)
- Primary completionJul 2017
- Study completionJul 2017
Why it stopped: Unable to enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DevelopmentStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annemarie Stroustrup, MD,MPH, Principal investigator, Ichan School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292680
- Sponsor's protocol ID
- GCO 14-1403
- Status last verified
- Nov 2017
- First submitted
- 12 Nov 2014
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Biomarkers for Exposures in the Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT02292680
- Acronym / sponsor ID
- GCO 14-1403
- Conditions
- Development
- Keywords
- dentin, environmental exposures, neurodevelopmental outcomes
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to enroll
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Jan 2017 (estimated)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 17 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children who were cared for as neonates in the Mount Sinai NICU
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Parent documented in Mount Sinai's database is no longer the legal guardian
- Non-English-speaking parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chemical Concentration in deciduous teeth
Time frame: up to 5 years
Teeth will be analyzed by a dentist and researcher trained in laser ablation inductively coupled plasma mass spectroscopy technology
3 secondary outcomes
Child Behavior Checklist
Time frame: up to 3 years
Wechsler Preschool and Primary Scale of Intelligence
Time frame: up to 3 years
Development Neuropsychological Assessment (NEPSY)
Time frame: up to 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annemarie Stroustrup, MD,MPH principal investigator
Ichan School of Medicine at Mount Sinai
Questions about this trial
What is this clinical trial studying?
An observational study of Development, run by Icahn School of Medicine at Mount Sinai.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemical Concentration in deciduous teeth (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2017.