Developmental Impact of NICU Exposures (DINE)

Completed

Conditions studied: Prematurity

In brief

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.

Key facts

Study ID

NCT03061890

Run by

Albert Einstein College of Medicine

People needed

600

Starts

2017-04-01

Expected to finish

2023-08-31

Last updated by the study team

2023-10-24

Who can join

Age: any, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 clinical sites in DINE.
• Newly recruited preterm infants admitted to the NICU at the Icahn School of Medicine at Mount Sinai
• Newly recruited preterm and term infants who participated in the PRISM study at University of Rochester
• 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 may not qualify 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

Where it is running

• University of Florida — Jacksonville, Florida, United States
• National Institute for Children's Health Quality — Boston, Massachusetts, United States
• Children's Health Care, Inc. — Minneapolis, Minnesota, United States
• University at Buffalo State University of New York — Buffalo, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• Albert Einstein College of Medicine — The Bronx, New York, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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