Clinical trial NCT01420029: Hospital-Based Phthalate Exposure in Very Low Birth Weight Neonates
Official title: Hospital-Based Phthalate Exposure in Very Low Birth Weight Neonates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Birth Weight Neonates
Keywords: Low birth weight neonates
Neurodevelopmental outcome
Thyroid dysfunction
Extrauterine growth
Plasticizers
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2011-08-19
Enrollment: 81
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates born at birthweights less than 1500 grams will be included.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Exposure to plasticizers
timeFrame: Length of stay in NICU which averages 8-10 weeks
measure: Performance on neonatal neurological screening tool
timeFrame: 4 weeks of age
measure: Performance on neonatal neurological screening tool
timeFrame: 34 weeks postconceptual age
Secondary outcomes:
measure: Extrauterine growth
timeFrame: Weekly during NICU stay with average stay of 8-10 weeks
measure: Thyroid dysfunction
timeFrame: 4 weeks of age
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital Neonatal Intensive Care Unit
state: New York
Study officials:
affiliation: Mount Sinai Hospital Division of Newborn Medicine
name: Annemarie Stroustrup, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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