Sound Processing Changes in Babies With Opioid Exposure

University of Rochester

Status

Completed

Conditions

Neonatal Abstinence Syndrome

Study type

Observational

Funder types

Other

Identifiers

NCT03567603

RSRB#72329

Details and patient eligibility

About

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.

Full description

This is a single center prospective study of neonates >36 weeks' gestation prenatally exposed to psychoactive substances and gestationally age-matched controls. Evoked response potentials on EEG in response to auditory oddball paradigms will be compared between cohorts. Analyses will try to identify differences in auditory processing using ANOVAs to compare the mismatch negativity measures, amplitudes and latencies as a function of study group.

Enrollment

37 patients

Sex

All

Ages

Under 20 days old

Volunteers

No Healthy Volunteers

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