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Summary

for people ages 3–10 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The DINE study will test the hypothesis that potentially avoidable NICU-based exposures contribute to the neuro-cognitive and somatic impairments prevalent among NICU graduates. This hypothesis is drawn from the documented impact of phthalate exposure on early development in term-born children, and the acknowledged presence of these toxic chemicals in the NICU. Third trimester in utero exposure to phthalates have been linked to poorer childhood performance in cognition, motor function, attention, hyperactivity and social behavior. Phthalate exposure is also associated with altered onset of puberty and asthma. The multi-site cohort and approach will clarify the role of NICU-based phthalate exposure on high-prevalence clinical outcomes.

Official Title

Developmental Impact of Neonatal Intensive Care Unit (NICU) Exposures: Environmental Influences on Child Health Outcomes (ECHO)

Details

Background: Each year in the United States, over 300,000 preterm infants are admitted to neonatal intensive care units (NICUs) where they are exposed to a chemical-intensive hospital environment during a developmentally vulnerable period. Many life-saving and supportive respiratory, nutritional, hematologic and pharmaceutical therapies in the NICU expose preterm infants to potentially harmful chemicals during a life stage analogous to the third trimester of gestation. The NIH-funded DINE study capitalizes on the infrastructure, biorepositories, and extensive clinical databases of four existing preterm cohorts to explore the hypothesis that early life exposure to phthalates adversely impacts neurodevelopment, lung function, growth, adiposity, and pubertal development in childhood.

The scientific premise of the DINE study is that early life exposure to phthalates, a class of chemical plasticizers ubiquitous in the NICU, has long-lasting harmful effects on child health and development, and that these harmful effects are magnified in children born preterm. This premise is based on strong evidence of multisystem adverse health effects in term-born children who are exposed to phthalates in utero during the third trimester of pregnancy or in early infancy. In preterm infants, however, rigorously obtained data on the health effects of phthalates are scant. Dermal, inhalational and intravenous exposures to phthalates are widespread in some NICUs, where preterm infants are cared for during the sensitive "third trimester" developmental window. Moreover, premature infants experience a high prevalence of the adverse health effects that are associated with early life exposures to phthalates in term-born children, including altered neurodevelopment, poor pulmonary function, and maladapted growth. A rigorous, well-designed, sufficiently powered study of NICU-based phthalate exposures and long-term health outcomes of preterm infants has the potential to change care practices, promote regulatory policy changes and lead to mitigation of phthalate exposures in the NICU.

Significance: The proposed research is expected to identify modifiable sources of developmental risk for NICU patients that can inform and improve hospital care and long-term outcome. Moreover, our findings could lead to relatively inexpensive NICU interventions, such as use of non-phthalate containing medical materials, dosing guidelines for elemental metals and guidance for parents and staff on infant stress-reduction, and policy changes (e.g. regulation of the phthalates used in medical devices or changes to the trace metal content of parenteral nutrition) with significant positive potential impacts on life-long morbidities common among NICU graduates. Information gleaned from studying our highly-exposed, highly-vulnerable population may elucidate health impacts of early life exposures that translate to risk reduction in the general population.

Keywords

Prematurity children's environmental health preterm birth phthalates NICU stress lung health neurodevelopment growth

Eligibility

You can join if…

Open to people ages 3–10

  • Children who were study participants in one of the four extant preterm cohorts (PROP,TOLSURF, NICU-HEALTH, and PENUT) that comprise the combined DINE cohort and who were followed to study endpoint at one of the 15 clinical sites in DINE.
  • Parents agreed to be re-contacted or local Institutional Review Board (IRB) grants permission to recontact families to obtain consent to participate in DINE.

You CAN'T join if...

  • Family requested that they not be contacted after their child completed the parent study
  • Family is unlikely to be available for long-term follow-up

Locations

  • University of Washington not yet accepting patients
    Seattle, Washington, 98195, United States
  • University of Texas Health Science Center at Houston not yet accepting patients
    Houston, Texas, 77030, United States
  • Children's Health Care, Inc. accepting new patients
    Minneapolis, Minnesota, 55404, United States
  • Arkansas Children's Research Institute not yet accepting patients
    Little Rock, Arkansas, 72202, United States
  • Vanderbilt University Medical Center accepting new patients
    Nashville, Tennessee, 37232, United States
  • Indiana University not yet accepting patients
    Indianapolis, Indiana, 46202, United States
  • Wake Forest University Health Sciences accepting new patients
    Winston-Salem, North Carolina, 27103, United States
  • University at Buffalo State University of New York not yet accepting patients
    Buffalo, New York, 14222, United States
  • University of Florida not yet accepting patients
    Jacksonville, Florida, 32209, United States
  • University of Rochester accepting new patients
    Rochester, New York, 14642, United States
  • Medical University of South Carolina not yet accepting patients
    Charleston, South Carolina, 29425, United States
  • Florida Hospital not yet accepting patients
    Orlando, Florida, 32804, United States
  • Icahn School of Medicine at Mount Sinai accepting new patients
    New York, New York, 10029, United States
  • Albert Einstein College of Medicine not yet accepting patients
    The Bronx, New York, 10461, United States
  • National Institute for Children's Health Quality not yet accepting patients
    Boston, Massachusetts, 02108, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Albert Einstein College of Medicine, Inc.
Links
NIH Environmental influences on Child Health Outcomes (ECHO) Program
ECHO DINE Community Collaboratory
ID
NCT03061890
Study Type
Observational [Patient Registry]
Last Updated
June 1, 2017
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