Sound Processing Changes in Babies With Opioid Exposure

NCT03567603 | Completed

• 1 other identifier: RSRB#72329
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Abstinence Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

opioid exposed neonates

prenatal opioid exposure

non-opioid exposed neonates

no prenatal opioid exposure

Eligibility Criteria

• Age: Up to 20 Days
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Ronnie Guillet, MD, PHD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: June 26, 2018
• Study Start: March 25, 2019
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)