Neonatal Abstinence SyndromeNCT03567603
Sound Processing Changes in Babies With Opioid Exposure
An observational study of Neonatal Abstinence Syndrome, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 20 days
- Conditions the study is for
- Neonatal Abstinence Syndrome
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2019to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 20 days
- All sexes
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: A Comparison of Mismatch Negativity Waveform Differences in Opioid-exposed and Non-exposed Neonates.
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.
Read the 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
- Neonatal Abstinence Syndrome
- Medical subject headings
- Neonatal Abstinence Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| opioid exposed neonates | prenatal opioid exposure | |
| non-opioid exposed neonates | no prenatal opioid exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start25 Mar 2019
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Abstinence SyndromeStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronnie Guillet, University of Rochester
- Investigators
- Ronnie Guillet, MD, PHD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567603
- Sponsor's protocol ID
- RSRB#72329
- Status last verified
- Jul 2023
- First submitted
- 13 Jun 2018
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Mismatch Negativity Waveform Differences in Opioid-exposed and Non-exposed Neonates.
- ClinicalTrials.gov ID
- NCT03567603
- Acronym / sponsor ID
- RSRB#72329
- Conditions
- Neonatal Abstinence Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| opioid exposed neonates | – | –prenatal opioid exposure |
| non-opioid exposed neonates | – | –no prenatal opioid exposure |
Who may qualify
- Ages
- Up to 20 days
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent with neonates with auditory cortical processing deficiencies
Time frame: baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronnie Guillet, MD, PHD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Abstinence Syndrome, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent with neonates with auditory cortical processing deficiencies (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.