PrematurityNCT05391633
Maternal Voice and Quantitative EEG (qEEG)
A study testing Recorded Maternal Voice in people with Prematurity and Development Delay, run by University of New Mexico at 1 site in United States.
Trial summary
A short-term randomized, blinded placebo-controlled trial, in premature infants in the neonatal intensive care unit (NICU) at 33-35 weeks post-conceptional age, of recorded maternal voice on quantitative EEG (spectral power density) as a marker of development. Read more about this study
- Who is it for?
- Ages 28 to 33 weeks
- Conditions the study is for
- Prematurity, Development Delay, Premature Birth
- What is being tested?
- Recorded Maternal Voice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2022to 12 Jun 2024
- Phase
- Interventional
- 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 28 to 33 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born at 28 0/7 - 32 3/7 weeks gestation (to allow for infants born at 32 3/7 weeks to have initial EEG performed after 72 hours of life and prior to initiating intervention or non-intervention arm at 33 0/7 weeks gestation)
- Mother available to provide voice recording, and have ability to converse and read in English (as the scripted content for the intervention will be provided in English)
Who cannot join
- Infant with Critical Congenital Cardiac Disease
- Infant with Chromosomal anomaly or Inborn Error of Metabolism
- Infant with known Neurologic disorder/abnormality - including hypoxic-ischemic encephalopathy (HIE), intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), seizure activity, anatomic abnormality
- Infant receiving antiepileptic or sedation medications prior to EEG
- Initial EEG abnormal with epileptiform activity or not consistent with corrected gestational age
- Mother not available to provide voice recording in English
Show all 11Show fewer
- Unable to obtain consent from mother due to maternal health issues following delivery (such as mother requiring intubation or sedation following delivery
- Mothers who are prisoners (as the study team would like to have continuing communication during the study period as needed)
- Mothers who are <18 years of age will not be approached for consent
- Any mother that is not able to consent due to having a legal representative will not be approached for consent
- Any infant that is planned to be placed for adoption, is in foster care or is a ward of the state
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
Official title: Effect of Recorded Maternal Voice on Quantitative EEG (qEEG) as a Marker for Developmental Risk in the Preterm Newborn
A short-term randomized, blinded placebo-controlled trial, in premature infants in the neonatal intensive care unit (NICU) at 33-35 weeks post-conceptional age, of recorded maternal voice on quantitative EEG (spectral power density) as a marker of development.
Read the detailed description
This will be a randomized placebo-controlled clinical trial. Infants consented to participate will be randomized into the intervention arm or non-intervention arm by sealed unmarked envelope.
All consented participants will have an initial EEG of 60-90 minutes duration, performed at 32 5/7 - 32 6/7 weeks (and after 72 hours of life).
Starting at 33 0/7 weeks corrected gestational age (regardless of birth gestation), eligible subjects will proceed with randomized intervention or placebo for a 2-week (14 day) intervention period.
All infants will receive a 2nd EEG of 30-60 minutes duration, performed between 35 0/7 - 35 6/7 weeks corrected gestational age, following completion of either the intervention or non-intervention arm (with the goal of the 2nd EEG occurring within 48 hours of infants having completed the intervention vs. non-intervention arm).
EEG technician and all persons reviewing, pruning and analyzing data from the qEEG will be blinded to whether the infant was in the intervention or the non-intervention arm.
- Conditions
- Prematurity, Development Delay, Premature Birth
- Being tested
- Recorded Maternal Voice, Placebo Recording
- Keywords
- quantitative EEG, Spectral Density Analysis, At Risk for Cognitive Delay, Premature Birth 28-32 weeks gestation
- Medical subject headings
- Premature Birth, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recorded Maternal VoiceBehavioural
60-minute looped recording of maternal voice, played once daily for 14 total days.
Placebo RecordingBehavioural
60-minute blank recording played once daily for 14 total days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Starting at 33 0/7 weeks corrected gestational age (regardless of birth gestation), infants randomized to the non-intervention arm will be played a blank recording of approximately 60 minutes duration, once every 24 hours for a 2-week (14 day) period. Receives: Behavioral: Placebo Recording |
| Recorded Voice Exposure | Experimental | Starting at 33 0/7 weeks corrected gestational age (regardless of birth gestation), infants randomized to the intervention arm will be played a recording of their mother's voice with approximately 60 minutes of scripted content, once per 24 hours for a 2-week (14 day) intervention period. (Mothers will be recorded reading a children's book and the recording will be looped to create the 60 minutes of content). Receives: Behavioral: Recorded Maternal Voice |
What is being measured
The primary outcome is the main question the study is designed to answer.
qEEG change: within
Change in relative spectral power, within group, of alpha (8-13 Hz) and beta (14-20 Hz) band
Measured: 2 weeks
qEEG change: between
Difference in relative spectral power, between groups, of alpha (8-13 Hz) and beta (14-20 Hz) band, at baseline and post-treatment
Measured: 2 weeks
Secondary outcomes (4)
Time to hospital discharge (between groups)
Birth Date to NICU discharge Date
Measured: Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.
Feeding
Time to full nippled feeds prior to discharge (between groups), gathered retrospectively by chart review at NICU discharge date.
Measured: Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.
NEC/Sepsis
Episodes of necrotizing enterocolitis (NEC) and/or Sepsis (between groups), gathered retrospectively by chart review at NICU discharge date.
Measured: Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.
Duration of O2 support
Duration of supplemental O2 needs (between groups), gathered retrospectively by chart review at NICU discharge date.
Measured: Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start15 Feb 2022
- Primary completion12 Jun 2024
- Study completion12 Jun 2024
Why it stopped: Per PI, enrollment stopped due to a lack of continued funding and staffing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Crossed design, between-group and within-group pre- and post-intervention changes in primary variable.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Cardon, University of New Mexico
- Investigators
- Aaron Cardon, MD, Study chair, University of New Mexico, Health Sciences CenterDawn Novak, MD, Principal investigator, University of New Mexico, Health Sciences CenterMeghan Groghan, Study director, University of New Mexico, Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391633
- Sponsor's protocol ID
- 21-417
- Status last verified
- Sep 2025
- First submitted
- 15 Feb 2022
- Last updated
- 15 Sep 2025
- 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 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Recorded Maternal Voice on Quantitative EEG (qEEG) as a Marker for Developmental Risk in the Preterm Newborn
- ClinicalTrials.gov ID
- NCT05391633
- Acronym / sponsor ID
- 21-417
- Conditions
- Prematurity, Development Delay, Premature Birth
- Keywords
- quantitative EEG, Spectral Density Analysis, At Risk for Cognitive Delay, Premature Birth 28-32 weeks gestation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per PI, enrollment stopped due to a lack of continued funding and staffing
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 12 Jun 2024 (actual)
- First posted
- 26 May 2022 (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.
A short-term randomized, blinded placebo-controlled trial, in premature infants in the neonatal intensive care unit (NICU) at 33-35 weeks post-conceptional age, of recorded maternal voice on quantitative EEG (spectral power density) as a marker of development.
Detailed description
This will be a randomized placebo-controlled clinical trial. Infants consented to participate will be randomized into the intervention arm or non-intervention arm by sealed unmarked envelope.
All consented participants will have an initial EEG of 60-90 minutes duration, performed at 32 5/7 - 32 6/7 weeks (and after 72 hours of life).
Starting at 33 0/7 weeks corrected gestational age (regardless of birth gestation), eligible subjects will proceed with randomized intervention or placebo for a 2-week (14 day) intervention period.
All infants will receive a 2nd EEG of 30-60 minutes duration, performed between 35 0/7 - 35 6/7 weeks corrected gestational age, following completion of either the intervention or non-intervention arm (with the goal of the 2nd EEG occurring within 48 hours of infants having completed the intervention vs. non-intervention arm).
EEG technician and all persons reviewing, pruning and analyzing data from the qEEG will be blinded to whether the infant was in the intervention or the non-intervention arm.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Crossed design, between-group and within-group pre- and post-intervention changes in primary variable.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Behavioral: Placebo RecordingStarting at 33 0/7 weeks corrected gestational age (regardless of birth gestation), infants randomized to the non-intervention arm will be played a blank recording of approximately 60 minutes duration, once every 24 hours for a 2-week (14 day) period. |
| Recorded Voice Exposure | Experimental | Behavioral: Recorded Maternal VoiceStarting at 33 0/7 weeks corrected gestational age (regardless of birth gestation), infants randomized to the intervention arm will be played a recording of their mother's voice with approximately 60 minutes of scripted content, once per 24 hours for a 2-week (14 day) intervention period. (Mothers will be recorded reading a children's book and the recording will be looped to create the 60 minutes of content). |
Who may qualify
- Ages
- 28 to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants born at 28 0/7 - 32 3/7 weeks gestation (to allow for infants born at 32 3/7 weeks to have initial EEG performed after 72 hours of life and prior to initiating intervention or non-intervention arm at 33 0/7 weeks gestation)
- Mother available to provide voice recording, and have ability to converse and read in English (as the scripted content for the intervention will be provided in English)
Key exclusion criteria (11 listed)
- Infant with Critical Congenital Cardiac Disease
- Infant with Chromosomal anomaly or Inborn Error of Metabolism
- Infant with known Neurologic disorder/abnormality - including hypoxic-ischemic encephalopathy (HIE), intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), seizure activity, anatomic abnormality
- Infant receiving antiepileptic or sedation medications prior to EEG
- Initial EEG abnormal with epileptiform activity or not consistent with corrected gestational age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recorded Maternal Voice60-minute looped recording of maternal voice, played once daily for 14 total days. | Behavioural | Recorded Voice Exposure |
| Placebo Recording60-minute blank recording played once daily for 14 total days. | Behavioural | Placebo |
Primary outcome
qEEG change: within
Time frame: 2 weeks
Change in relative spectral power, within group, of alpha (8-13 Hz) and beta (14-20 Hz) band
qEEG change: between
Time frame: 2 weeks
Difference in relative spectral power, between groups, of alpha (8-13 Hz) and beta (14-20 Hz) band, at baseline and post-treatment
4 secondary outcomes
Time to hospital discharge (between groups)
Time frame: Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.
Feeding
Time frame: Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.
NEC/Sepsis
Time frame: Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.
Duration of O2 support
Time frame: Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.
Results and safety
The study was stopped early (reason given: Per PI, enrollment stopped due to a lack of continued funding and staffing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- 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.
Aaron Cardon, MD study chair
University of New Mexico, Health Sciences Center
Dawn Novak, MD principal investigator
University of New Mexico, Health Sciences Center
Meghan Groghan study director
University of New Mexico, Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recorded Maternal Voice in people with Prematurity and Development Delay, run by University of New Mexico 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 2 inclusion and 11 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: stopped early, as of the sponsor's last update on 15 Sep 2025. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Per PI, enrollment stopped due to a lack of continued funding and staffing). Results are not available in the source record.
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?
qEEG change: within (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 15 Sep 2025; AzTrials last refreshed its copy on 28 Oct 2026.