Hospital-Based Phthalate Exposure in Very Low Birth Weight Neonates
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|ClinicalTrials.gov Identifier: NCT01420029|
Recruitment Status : Completed
First Posted : August 19, 2011
Last Update Posted : September 20, 2013
|Condition or disease|
|Low Birth Weight Neonates|
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|
|Actual Enrollment :||81 participants|
|Official Title:||Hospital-Based Phthalate Exposure in Very Low Birth Weight Neonates|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
- Exposure to plasticizers [ Time Frame: Length of stay in NICU which averages 8-10 weeks ]Extent of exposure to plasticizers
- Performance on neonatal neurological screening tool [ Time Frame: 4 weeks of age ]
- Performance on neonatal neurological screening tool [ Time Frame: 34 weeks postconceptual age ]
- 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
- Thyroid dysfunction [ Time Frame: 4 weeks of age ]Presence of thyroid dysfunction on thyroid function tests
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420029
|United States, New York|
|Mount Sinai Hospital Neonatal Intensive Care Unit|
|New York, New York, United States, 10029|
|Principal Investigator:||Annemarie Stroustrup, MD, MPH||Mount Sinai Hospital Division of Newborn Medicine|