NCT05391633

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: All
• Age: 28 Weeks – 33 Weeks
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Recorded Maternal Voice	60-minute looped recording of maternal voice, played once daily for 14 total days.
BEHAVIORAL	Placebo Recording	60-minute blank recording played once daily for 14 total days.

Timeline

• Start date: 2022-02-15
• Primary completion: 2024-06-12
• Completion: 2024-06-12
• First posted: 2022-05-26
• Last updated: 2025-09-15

Locations

1 site across 1 country: United States