Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-25 @ 5:03 PM
Study NCT ID:
NCT03567603
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2018-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sound Processing Changes in Babies With Opioid Exposure
Sponsor:
University of Rochester
Organization:
Study Overview
Official Title:
A Comparison of Mismatch Negativity Waveform Differences in Opioid-exposed and Non-exposed Neonates.
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: