Sound Processing Changes in Babies With Opioid Exposure

Completed

• Conditions: Neonatal Abstinence Syndrome

• Registration Number: NCT03567603
• Lead Sponsor: University of Rochester

Brief 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.

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 Timeline

• Study First Submitted: 2018-06-13
• Study First Submitted QC: 2018-06-13
• Study First Posted: 2018-06-26
• Study Start: 2019-03-25
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent with neonates with auditory cortical processing deficiencies	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.

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States