An observational study in Neonatal Abstinence Syndrome, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged Up to 20 Days. Per ClinicalTrials.gov, last updated 2023-07-20.
Sponsored by University of Rochester · Observational
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.
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.
65 studies on the registry are indexed under Neonatal Abstinence Syndrome; 6 are open to participants now.
This study's enrollment of 37 is below the median of 50 across 15 observational studies indexed under Neonatal Abstinence Syndrome.
Browse Neonatal Abstinence Syndrome studies →University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
prenatal opioid exposure
no prenatal opioid exposure
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.
Time frame: baseline
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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University of Rochester