Sound Processing Changes in Babies With Opioid Exposure

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neonatal Abstinence Syndrome Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Mental Disorders Substance-Related Disorders

Age range

Up to 20 day

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Percent with neonates with auditory cortical processing deficiencies

Time frame: baseline

A bone conducting sound playback lead will be placed over a bony prominence on the skull to transmit the auditory oddball paradigm that will be repeatedly played via this lead. The oddball paradigm will consist of a repeating sound loop including multiple identical 5-30 decibels tones of same duration interspersed with single 5-30 decibels tone of different pitch but same duration (deviant tone). Continuous EEG recordings will be collected during playback.

EEG tracings will be analyzed specifically for the mismatch negativity waveforms. Comparisons will be made between the deviant and standard responses (sound tones) and the percentage of neonates with no difference between the standard and deviant waveforms will be determined.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2023
Study completion: 2023
First posted: Jun 26, 2018
Registry last updated: Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed