Hospital-Based Phthalate Exposure in Very Low Birth Weight Neonates

Completed

• Conditions: Low Birth Weight Neonates

• Registration Number: NCT01420029
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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.

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 Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-17
• Study First Submitted QC: 2011-08-18
• Study First Posted: 2011-08-19
• Status Verified: 2013-09
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2013-09-19
• Last Update Posted: 2013-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exposure to plasticizers	Length of stay in NICU which averages 8-10 weeks	Extent of exposure to plasticizers
Performance on neonatal neurological screening tool	34 weeks postconceptual age

Secondary Outcome Measures

Name	Time	Method
Extrauterine growth	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
Thyroid dysfunction	4 weeks of age	Presence of thyroid dysfunction on thyroid function tests

Trial Locations

Locations (1)

Mount Sinai Hospital Neonatal Intensive Care Unit; 🇺🇸 New York, New York, United States