Sound Processing Changes in Babies With Opioid Exposure



Status:Recruiting
Healthy:No
Age Range:Any
Updated:4/6/2019
Start Date:March 25, 2019
End Date:February 28, 2020
Contact:Perihan Ulema, MD
Email:perihan_ulema@urmc.rochester.edu
Phone:201-328-5207

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A Comparison of Mismatch Negativity Waveform Differences in Opioid-exposed and Non-exposed Neonates.

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.


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
We found this trial at
1
site
601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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