Sound Processing Changes in Babies With Opioid Exposure

Neonatal Abstinence Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03567603
• Other study ID #: RSRB#72329
• Status: Completed
• Start date: March 25, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Gender: All
• Age group: N/A to 20 Days

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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