Hospital-Based Phthalate Exposure in Very Low Birth Weight Neonates

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01420029
First received: August 17, 2011
Last updated: September 19, 2013
Last verified: September 2013
  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:


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


Enrollment: 81
Study Start Date: August 2011
Study Completion Date: September 2013
Primary Completion Date: September 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

Locations
United States, New York
Mount Sinai Hospital Neonatal Intensive Care Unit
New York, New York, United States, 10029
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:
Johnson S, Hollis C, Kochhar P, Hennessy E, Wolke D, Marlow N. Psychiatric disorders in extremely preterm children: longitudinal finding at age 11 years in the EPICure study. J Am Acad Child Adol Psychiat 2010;49:453-463.

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: September 19, 2013
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 April 15, 2014