Maternal Voice and Quantitative EEG (qEEG)

NCT ID: NCT05391633

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2024-06-12

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo Recording

Intervention Type: BEHAVIORAL

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

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).

Group Type: EXPERIMENTAL

Recorded Maternal Voice

Intervention Type: BEHAVIORAL

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

Interventions

Recorded Maternal Voice

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

Intervention Type: BEHAVIORAL

Placebo Recording

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 28 Weeks
• Maximum Eligible Age: 33 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Aaron Cardon

Assistant Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aaron Cardon, MD

Role: STUDY_CHAIR

University of New Mexico, Health Sciences Center

Dawn Novak, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico, Health Sciences Center

Meghan Groghan

Role: STUDY_DIRECTOR

University of New Mexico, Health Sciences Center

Locations

University of New Mexico

Albuquerque, New Mexico, United States

Countries

United States

Other Identifiers

21-417

Identifier Type: -

Identifier Source: org_study_id