Hospital-Based Phthalate Exposure in Very Low Birth Weight Neonates

September 19, 2013 updated by: Icahn School of Medicine at Mount Sinai
In this observational pilot project, the investigators plan to document duration and sources of exposure to plasticizers in infants born at birth weights less than 1500 grams. The investigators will examine the association between exposure to plasticizers and outcomes such as performance on a neurological screening tool, extrauterine growth, and thyroid function.

Study Overview

Status

Completed

Conditions

Detailed Description

High levels of exposure to certain plasticizers, specifically, phthalates and Bisphenol-A (BPA) have been shown to affect intelligence and behavior in school-age children, as well as to disrupt growth and some endocrine functions. Items used in the care of infants in the Neonatal Intensive Care Unit (NICU) contain phthalates and BPA. Babies admitted for long periods of time to the NICU, could be exposed to high levels of these potentially harmful plastics. In this study, the investigators are interested in documenting duration and sources of exposure to plasticizers during the NICU admission of infants born weighing less than 1500 grams. The investigators will examine the association between NICU exposure to plasticizers and performance on a neurological screening test that predicts future behavior, growth after birth, and the presence of any thyroid dysfunction.

The investigators plan to enroll 50 neonates in our study. The investigators will catalog all exposure to plasticizers during the infant's NICU admission and assign each baby a risk level of exposure. The investigators will then test each infant's performance on a neurological screening tool, measure growth from birth and assess whether or not each infant has thyroid dysfunction and correlate each outcome with exposure risk level. The investigators will also collect urine samples from each baby to store for possible future analysis.

The investigators hypothesize that neonates with higher levels of exposure will demonstrate worse performance on the neurological screening tool, poor growth, and abnormal thyroid function.

Study Type

Observational

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Hospital Neonatal Intensive Care Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Neonates born at birthweights less than 1500 grams will be included.

Description

Inclusion Criteria:

  • Neonates born less than 1500 grams that are admitted to the Mount Sinai Hospital NICU

Exclusion Criteria:

  • Chromosomal abnormality or other genetic disorder
  • Diagnosis of hypoxic-ischemic encephalopathy
  • Inborn error of metabolism
  • Congenital renal disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exposure to plasticizers
Time Frame: Length of stay in NICU which averages 8-10 weeks
Extent of exposure to plasticizers
Length of stay in NICU which averages 8-10 weeks
Performance on neonatal neurological screening tool
Time Frame: 4 weeks of age
4 weeks of age
Performance on neonatal neurological screening tool
Time Frame: 34 weeks postconceptual age
34 weeks postconceptual age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extrauterine growth
Time Frame: Weekly during NICU stay with average stay of 8-10 weeks
Weight, head circumference and length will be recorded weekly during the neonate's stay in the NICU
Weekly during NICU stay with average stay of 8-10 weeks
Thyroid dysfunction
Time Frame: 4 weeks of age
Presence of thyroid dysfunction on thyroid function tests
4 weeks of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Annemarie Stroustrup, MD, MPH, Mount Sinai Hospital Division of Newborn Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

August 17, 2011

First Submitted That Met QC Criteria

August 18, 2011

First Posted (ESTIMATE)

August 19, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 20, 2013

Last Update Submitted That Met QC Criteria

September 19, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 11-0664
  • 0285-7451 (OTHER: CEHC Pilot Projects Fund)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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