Sound Processing Changes in Babies With Opioid Exposure

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Abstinence Syndrome

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

• Study Contact: Name: Ronnie Guillet, MD, PhD; Phone Number: 201-328-5207; Email: perihan_ulema@urmc.rochester.edu
• Study Contact Backup: Name: John Foxe, PhD; Email: john_foxe@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 weeks (Child)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Investigators with routine access to infant and maternal records will identify subjects based on review of patient charts upon admission to the NICU or nursery.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
opioid exposed neonates; prenatal opioid exposure
non-opioid exposed neonates; no prenatal opioid exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent with neonates with auditory cortical processing deficiencies	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.	baseline

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Ronnie Guillet, MD, PhD, University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2019
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: June 13, 2018
• First Submitted That Met QC Criteria: June 13, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Infant, Newborn, Diseases; Neonatal Abstinence Syndrome
• Other Study ID Numbers: RSRB#72329

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No