Maternal Voice and Quantitative EEG (qEEG)

NCT05391633 | Terminated

• 1 other identifier: 21-417
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prematurity; Development Delay; Premature Birth

Keywords

quantitative EEG; Spectral Density Analysis; At Risk for Cognitive Delay; Premature Birth 28-32 weeks gestation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Time to hospital discharge (between groups)

  Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.

• Feeding

  Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.

• NEC/Sepsis

  Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.

• Duration of O2 support

  Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.

Study Arms (2)

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.

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).

Behavioral: Recorded Maternal Voice

Interventions

Recorded Maternal Voice BEHAVIORAL

60-minute looped recording of maternal voice, played once daily for 14 total days.

Recorded Voice Exposure

Placebo Recording BEHAVIORAL

60-minute blank recording played once daily for 14 total days.

Placebo

Eligibility Criteria

• Age: 28 Weeks - 33 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Premature Birth; Learning Disabilities

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Aaron Cardon, MD

  University of New Mexico, Health Sciences Center

  STUDY CHAIR

• Dawn Novak, MD

  University of New Mexico, Health Sciences Center

  PRINCIPAL INVESTIGATOR

• Meghan Groghan

  University of New Mexico, Health Sciences Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: NICU Investigator will provide the intervention versus placebo, with subject identification unlinked to randomization status. EEG reader, qEEG pruner and qEEG analyst will remain blinded to subject allocation until all data is extracted from each subject's EEG and medical record. To further prevent bias, group assignment unidentified as to control versus intervention will be maintained until all statistical analysis is complete.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Model Details: Crossed design, between-group and within-group pre- and post-intervention changes in primary variable.

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: May 26, 2022
• Study Start: February 15, 2022
• Primary Completion: June 12, 2024
• Study Completion: June 12, 2024
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)