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NICU-HEALTH (Hospital Exposures and Long-Term Health)

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ClinicalTrials.gov Identifier: NCT01963065
Recruitment Status : Recruiting
First Posted : October 16, 2013
Last Update Posted : October 26, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief Summary:
The purpose of this study is to evaluate whether babies are exposed to significant levels of chemicals during their stay in the neonatal intensive care unit (NICU). For example, other research studies have shown that babies are exposed to plasticizers (bisphenol A, phthalates) in the NICU. Plasticizers are chemicals that are used to make plastic medical equipment soft and flexible. The research team wants to find out whether the amount of plasticizer and other chemicals babies may be exposed to in the NICU makes a difference in how they grow and how they perform on neurologic tests.

Condition or disease
Preterm Birth

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chemical Exposures and Infant Outcomes in the Neonatal Intensive Care Unit
Study Start Date : March 2015
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Group/Cohort
Very low birth weight infant or moderately pre-term infant
All neonates born at Mount Sinai with birth weight < 1500g or gestational age of 28 to 32 weeks



Primary Outcome Measures :
  1. Chemical biomarker levels in urine [ Time Frame: 1-2 times per week for duration of the NICU hospitalization, up to 5 months ]
    Urine specimens collected weekly, stool specimens collected weekly, hair and blood collected once, cord blood and placental tissue collected once

  2. Chemical biomarker levels in stool [ Time Frame: once per week up to 25 weeks ]
  3. Chemical biomarker levels in hair sample [ Time Frame: at 34 weeks post-menstrual age ]
  4. Chemical biomarker levels in blood [ Time Frame: at 34 weeks post-menstrual age ]
  5. Chemical biomarker levels in Cord Blood [ Time Frame: on day of birth ]
  6. Chemical biomarker levels in Placental Tissue [ Time Frame: on day of birth ]

Secondary Outcome Measures :
  1. NICU Network Neurobehavioral Scale [ Time Frame: at 34-42 weeks postmenstrual age ]
    Performance on a scale of newborn neurodevelopment designed both for use in newborns exposed to toxins in utero and for evaluation of infants born preterm

  2. High-density electroencephalogram [ Time Frame: at 34-42 weeks postmenstrual age ]
    High-density EEG is a measure of infant neurologic function. The use of commercially-available high-density array mesh caps (Electrical Geodesics, Inc., Eugene, OR) allows the EEG to be placed on a study subject in under five minutes, and is comfortable enough to remain in place through multiple care activities and during sleep. High-density EEG has been used successfully used to demonstrate varying electrocortical functional connectivity between babies born at term or preterm, and has been correlated to performance on neurocognitive tests later in life.


Biospecimen Retention:   Samples With DNA
Samples with DNA - samples retained, with potential for extraction of DNA from at least one fo the types of samples retained (e.g., frozen tissue, whole blood)


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All neonates admitted to the Mount Sinai NICU who are classified as VLBW will be eligible for enrollment.
Criteria

Inclusion Criteria:

  • Birth at Mount Sinai Hospital
  • Birth weight < 1500g
  • Gestational Age of 28-33 weeks

Exclusion Criteria:

  • Birth at an outside hospital
  • Chromosomal abnormality or other genetic disorder
  • Diagnosis of hypoxic-ischemic encephalopathy
  • Inborn error of metabolism
  • Congenital renal disease
  • Intestinal obstruction
  • Major congenital anomaly

Information from the National Library of Medicine

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): NCT01963065


Contacts
Contact: Annemarie Stroustrup, MD, MPH 212-241-6186 annemarie.stroustrup@mssm.edu

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Principal Investigator: Annemarie Stroustrup, MD, MPH         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institutes of Health (NIH)
Investigators
Principal Investigator: Annemarie Stroustrup, MD, MPH Icahn School of Medicine at Mount Sinai

Publications:
Forrest SR, Burrows PE, Stroustrup A, Strickland D. Intense second harmonic generation and long range structural ordering in thin films of an organic salt grown by vapor phase deposition. Appl Phys Lett. 1996;68:1326-8

Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01963065     History of Changes
Other Study ID Numbers: GCO 12-0332
NIH 1K23 ES022268-01
First Posted: October 16, 2013    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018

Keywords provided by Icahn School of Medicine at Mount Sinai:
Children's environmental health
preterm birth
newborns
bisphenol A
BPA
phthalates
metals exposure
very low birth weight
NICU

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications