CompletedNot Applicable

Sound Processing Changes in Babies With Opioid Exposure

United States37 participantsStarted 2019-03-25

Plain-language 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.

Who can participate

Age range20 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percent with neonates with auditory cortical processing deficiencies

Timeframe: baseline

Trial details

NCT IDNCT03567603

SponsorUniversity of Rochester

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-06-30

View on ClinicalTrials.gov More Neonatal Abstinence Syndrome trials