Trials / Completed
CompletedNCT03567603
Sound Processing Changes in Babies With Opioid Exposure
A Comparison of Mismatch Negativity Waveform Differences in Opioid-exposed and Non-exposed Neonates.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 37 (actual)
- Sponsor
- University of Rochester · Academic / Other
- Sex
- All
- Age
- 20 Days
- Healthy volunteers
- —
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.
Conditions
Timeline
- Start date
- 2019-03-25
- Primary completion
- 2023-06-30
- Completion
- 2023-06-30
- First posted
- 2018-06-26
- Last updated
- 2023-07-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03567603. Inclusion in this directory is not an endorsement.