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Completed

NCT Number: NCT01420029

Hospital-Based Phthalate Exposure in Very Low Birth Weight Neonates

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Mount Sinai Hospital Neonatal Intensive Care Unit

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Exposure to plasticizers

    Time frame: Length of stay in NICU which averages 8-10 weeks

    Extent of exposure to plasticizers

  2. Performance on neonatal neurological screening tool

    Time frame: 4 weeks of age

  3. Performance on neonatal neurological screening tool

    Time frame: 34 weeks postconceptual age

Secondary outcomes

  1. 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

  2. Thyroid dysfunction

    Time frame: 4 weeks of age

    Presence of thyroid dysfunction on thyroid function tests

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 19, 2011
Registry last updated
Sep 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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