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Hospital-Based Phthalate Exposure in Very Low Birth Weight Neonates

Hospital-Based Phthalate Exposure in Very Low Birth Weight Neonates

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01420029
Enrollment
81
Registered
2011-08-19
Start date
2011-08-31
Completion date
2013-09-30
Last updated
2013-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Birth Weight Neonates

Keywords

Low birth weight neonates, Neurodevelopmental outcome, Thyroid dysfunction, Extrauterine growth, Plasticizers

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.

Interventions

None listed

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Exposure to plasticizersLength of stay in NICU which averages 8-10 weeksExtent of exposure to plasticizers
Performance on neonatal neurological screening tool4 weeks of age

Secondary

MeasureTime frameDescription
Extrauterine growthWeekly during NICU stay with average stay of 8-10 weeksWeight, head circumference and length will be recorded weekly during the neonate's stay in the NICU
Thyroid dysfunction4 weeks of agePresence of thyroid dysfunction on thyroid function tests

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026