Rochester, New York 14642


Purpose:

The purpose of this study is to identify problems with interpreting sounds in babies that have been exposed to opioids prior to birth. Being able to identify these issues in infancy may allow us to find children who may have problems with language learning later in life so that we can try to minimize these.


Criteria:

Inclusion Criteria: - Gestational age ≥ 36 weeks, confirmation of dates via ultrasound or last menstrual period - Prenatal opioid exposure ("exposed"), confirmed via admitted use or newborn drug screen; no prenatal opioid exposure ("control") by maternal report or testing - All races, ethnicities, sexes to be included - Informed permission form signed by mother Exclusion Criteria: - Birth weight ≤ 3rd percentile or ≥ 97th percentile for gestational age - Have comorbid medical disorders including; those associated with sensorineural hearing loss, significant congenital anomalies, congenital heart disease, known brain injury/malformations - Infants requiring mechanical ventilation - Infants requiring continuous sedation


NCT ID:

NCT03567603


Primary Contact:

Principal Investigator
Ronnie Guillet, MD, PHD
University of Rochester

Perihan Ulema, MD
Phone: 201-328-5207
Email: perihan_ulema@urmc.rochester.edu


Backup Contact:

Email: ronnie_guillet@urmc.rochester.edu
Ronnie Guillet, MD, PHD
Phone: 585-275-6209


Location Contact:

Rochester, New York 14642
United States

Perihan Ulema, MD

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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