Trials Sponsors Conditions Drugs Pricing

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

AgeUp to 20 Days

Sexall

Age GroupsChild (0-17)

Sampling MethodNon-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

Sponsors & Collaborators

University of Rochester
Otherlead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

Ronnie Guillet, MD, PHD
University of Rochester
PRINCIPAL INVESTIGATOR

Enrollment

37 participants (actual enrollment reported by the registry).

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

Actual (reported)

Sound Processing Changes in Babies With Opioid Exposure

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

opioid exposed neonates

non-opioid exposed neonates

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

opioid exposed neonates

non-opioid exposed neonates

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations