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Sound Processing Changes in Babies With Opioid Exposure

Sponsor
University of Rochester (Other)
Overall Status
Recruiting
CT.gov ID
NCT03567603
Collaborator
(none)
40
Enrollment
1
Location
39.2
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    A Comparison of Mismatch Negativity Waveform Differences in Opioid-exposed and Non-exposed Neonates.
    Actual Study Start Date :
    Mar 25, 2019
    Anticipated Primary Completion Date :
    Jun 30, 2022
    Anticipated Study Completion Date :
    Jun 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    opioid exposed neonates

    prenatal opioid exposure
    non-opioid exposed neonates

    no prenatal opioid exposure

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 20 Days
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Rochester Medical Center Rochester New York United States 14642

    Sponsors and Collaborators

    • University of Rochester

    Investigators

    • Principal Investigator: Ronnie Guillet, MD, PHD, University of Rochester

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ronnie Guillet, Professor of Pediatrics, University of Rochester
    ClinicalTrials.gov Identifier:
    NCT03567603
    Other Study ID Numbers:
    • RSRB#72329
    First Posted:
    Jun 26, 2018
    Last Update Posted:
    Sep 21, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neonatal Abstinence Syndrome

    Study Results

    No Results Posted as of Sep 21, 2021