Hospital-Based Phthalate Exposure in Very Low Birth Weight Neonates - Full Text View

Purpose

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.

Condition
Low Birth Weight Neonates

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Hospital-Based Phthalate Exposure in Very Low Birth Weight Neonates

Resource links provided by NLM:

MedlinePlus related topics: Birth Weight Thyroid Diseases

U.S. FDA Resources

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:

Exposure to plasticizers [ Time Frame: Length of stay in NICU which averages 8-10 weeks ] [ Designated as safety issue: No ]
Extent of exposure to plasticizers
Performance on neonatal neurological screening tool [ Time Frame: 4 weeks of age ] [ Designated as safety issue: No ]
Performance on neonatal neurological screening tool [ Time Frame: 34 weeks postconceptual age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Extrauterine growth [ Time Frame: Weekly during NICU stay with average stay of 8-10 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Presence of thyroid dysfunction on thyroid function tests

Biospecimen Retention: Samples With DNA

Urine, whole blood

Estimated Enrollment:	50
Study Start Date:	August 2011
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Neonates born at birthweights less than 1500 grams will be included.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420029

Contacts

Contact: Jennifer J Bragg, MD	212-241-6186	jennifer.bragg@mssm.edu
Contact: Annemarie Stroustrup, MD, MPH

Locations

United States, New York
Mount Sinai Hospital Neonatal Intensive Care Unit	Recruiting
New York, New York, United States, 10029
Contact: Jennifer J Bragg, MD 212-241-6186 jennifer.bragg@mssm.edu
Contact: Annemarie Stroustrup, MD, MPH 212-241-6186 annemarie.stroustrup@mssm.edu
Principal Investigator: Annemarie Stroustrup, MD, MPH
Sub-Investigator: Mary S Wolff, PhD
Sub-Investigator: Jennifer J Bragg, MD
Sub-Investigator: Cheryl R Stein, PhD

Sponsors and Collaborators

Mount Sinai School of Medicine

Investigators

Principal Investigator:

Annemarie Stroustrup, MD, MPH

Mount Sinai Hospital Division of Newborn Medicine

More Information

Publications:

Wolff MS, Engel SM, Berkowitz GS, Ye X, Silva MJ, Zhu C, Wetmur J, Calafat AM. Prenatal phenol and phthalate exposures and birth outcomes. Environ Health Perspect. 2008 Aug;116(8):1092-7.

Engel SM, Miodovnik A, Canfield RL, Zhu C, Silva MJ, Calafat AM, Wolff MS. Prenatal phthalate exposure is associated with childhood behavior and executive functioning. Environ Health Perspect. 2010 Apr;118(4):565-71. Epub 2010 Jan 8.

Calafat AM, Needham LL, Silva MJ, Lambert G. Exposure to di-(2-ethylhexyl) phthalate among premature neonates in a neonatal intensive care unit. Pediatrics. 2004 May;113(5):e429-34.

Calafat AM, Weuve J, Ye X, Jia LT, Hu H, Ringer S, Huttner K, Hauser R. Exposure to bisphenol A and other phenols in neonatal intensive care unit premature infants. Environ Health Perspect. 2009 Apr;117(4):639-44. Epub 2008 Dec 10.

Weuve J, Sánchez BN, Calafat AM, Schettler T, Green RA, Hu H, Hauser R. Exposure to phthalates in neonatal intensive care unit infants: urinary concentrations of monoesters and oxidative metabolites. Environ Health Perspect. 2006 Sep;114(9):1424-31.

Loff S, Kabs F, Witt K, Sartoris J, Mandl B, Niessen KH, Waag KL. Polyvinylchloride infusion lines expose infants to large amounts of toxic plasticizers. J Pediatr Surg. 2000 Dec;35(12):1775-81.

Subotic U, Hannmann T, Kiss M, Brade J, Breitkopf K, Loff S. Extraction of the plasticizers diethylhexylphthalate and polyadipate from polyvinylchloride nasogastric tubes through gastric juice and feeding solution. J Pediatr Gastroenterol Nutr. 2007 Jan;44(1):71-6.

Kim BN, Cho SC, Kim Y, Shin MS, Yoo HJ, Kim JW, Yang YH, Kim HW, Bhang SY, Hong YC. Phthalates exposure and attention-deficit/hyperactivity disorder in school-age children. Biol Psychiatry. 2009 Nov 15;66(10):958-63. Epub 2009 Sep 12.

Tanaka T. Reproductive and neurobehavioural effects of bis(2-ethylhexyl) phthalate (DEHP) in a cross-mating toxicity study of mice. Food Chem Toxicol. 2005 Apr;43(4):581-9.

Price SC, Chescoe D, Grasso P, Wright M, Hinton RH. Alterations in the thyroids of rats treated for long periods with di-(2-ethylhexyl) phthalate or with hypolipidaemic agents. Toxicol Lett. 1988 Jan;40(1):37-46.

Sugiyama S, Shimada N, Miyoshi H, Yamauchi K. Detection of thyroid system-disrupting chemicals using in vitro and in vivo screening assays in Xenopus laevis. Toxicol Sci. 2005 Dec;88(2):367-74. Epub 2005 Sep 22.

Silva MJ, Reidy JA, Herbert AR, Preau JL Jr, Needham LL, Calafat AM. Detection of phthalate metabolites in human amniotic fluid. Bull Environ Contam Toxicol. 2004 Jun;72(6):1226-31. No abstract available.

Engel SM, Berkowitz GS, Barr DB, Teitelbaum SL, Siskind J, Meisel SJ, Wetmur JG, Wolff MS. Prenatal organophosphate metabolite and organochlorine levels and performance on the Brazelton Neonatal Behavioral Assessment Scale in a multiethnic pregnancy cohort. Am J Epidemiol. 2007 Jun 15;165(12):1397-404. Epub 2007 Apr 3.

Engel SM, Zhu C, Berkowitz GS, Calafat AM, Silva MJ, Miodovnik A, Wolff MS. Prenatal phthalate exposure and performance on the Neonatal Behavioral Assessment Scale in a multiethnic birth cohort. Neurotoxicology. 2009 Jul;30(4):522-8. Epub 2009 Apr 16.

Fenster L, Eskenazi B, Anderson M, Bradman A, Hubbard A, Barr DB. In utero exposure to DDT and performance on the Brazelton neonatal behavioral assessment scale. Neurotoxicology. 2007 May;28(3):471-7. Epub 2007 Jan 10.

Ohgi S, Arisawa K, Takahashi T, Kusumoto T, Goto Y, Akiyama T, Saito H. Neonatal behavioral assessment scale as a predictor of later developmental disabilities of low birth-weight and/or premature infants. Brain Dev. 2003 Aug;25(5):313-21.

Clark RH, Thomas P, Peabody J. Extrauterine growth restriction remains a serious problem in prematurely born neonates. Pediatrics. 2003 May;111(5 Pt 1):986-90.

De Curtis M, Rigo J. Extrauterine growth restriction in very-low-birthweight infants. Acta Paediatr. 2004 Dec;93(12):1563-8.

Ferguson SA, Flynn KM, Delclos KB, Newbold RR. Maternal and offspring toxicity but few sexually dimorphic behavioral alterations result from nonylphenol exposure. Neurotoxicol Teratol. 2000 Jul-Aug;22(4):583-91.

Hinton RH, Mitchell FE, Mann A, Chescoe D, Price SC, Nunn A, Grasso P, Bridges JW. Effects of phthalic acid esters on the liver and thyroid. Environ Health Perspect. 1986 Dec;70:195-210.

Pereira C, Mapuskar K, Vaman Rao C. A two-generation chronic mixture toxicity study of Clophen A60 and diethyl phthalate on histology of adrenal cortex and thyroid of rats. Acta Histochem. 2007;109(1):29-36. Epub 2006 Nov 17.

Responsible Party:	Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:	NCT01420029 History of Changes
Other Study ID Numbers:	GCO 11-0664, 0285-7451
Study First Received:	August 17, 2011
Last Updated:	October 15, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:

Low birth weight neonates
Neurodevelopmental outcome
Thyroid dysfunction
Extrauterine growth
Plasticizers

Additional relevant MeSH terms:

Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013