Maternal Voice and Quantitative EEG (qEEG)

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.

Study Overview

• Status: Terminated
• Conditions: Premature Birth; Prematurity; Development Delay
• Intervention / Treatment: Behavioral: Placebo Recording; Behavioral: Recorded Maternal Voice

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 7 months (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 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.	Behavioral: Placebo Recording; 60-minute blank recording played once daily for 14 total days.
Experimental: Recorded Voice Exposure; 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).	Behavioral: Recorded Maternal Voice; 60-minute looped recording of maternal voice, played once daily for 14 total days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
qEEG change: within	Change in relative spectral power, within group, of alpha (8-13 Hz) and beta (14-20 Hz) band	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	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to hospital discharge (between groups)	Birth Date to NICU discharge Date	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.	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.	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.	Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.

Collaborators and Investigators

• Sponsor: University of New Mexico
• Investigators: Study Chair: Aaron Cardon, MD, University of New Mexico, Health Sciences Center; Principal Investigator: Dawn Novak, MD, University of New Mexico, Health Sciences Center; Study Director: Meghan Groghan, University of New Mexico, Health Sciences Center

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): June 12, 2024
• Study Completion (Actual): June 12, 2024

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: quantitative EEG; Spectral Density Analysis; At Risk for Cognitive Delay; Premature Birth 28-32 weeks gestation
• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Communication Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Premature Birth; Learning Disabilities
• Other Study ID Numbers: 21-417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No