Maternal Voice and Quantitative EEG (qEEG)

Not Applicable

Active, not recruiting

• Conditions: Prematurity; Premature Birth; Development Delay
• Interventions: Behavioral: Recorded Maternal Voice; Behavioral: Placebo Recording

• Registration Number: NCT05391633
• Lead Sponsor: University of New Mexico

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.

Study Timeline

• Study Start: 2022-02-15
• Study First Submitted: 2022-02-15
• Study First Submitted QC: 2022-05-20
• Study First Posted: 2022-05-26
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10
• Primary Completion: 2025-08-01
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recorded Voice Exposure	Recorded Maternal Voice	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).
Placebo	Placebo Recording	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.

Primary Outcome Measures

Name	Time	Method
qEEG change: within	2 weeks	Change in relative spectral power, within group, of alpha (8-13 Hz) and beta (14-20 Hz) band
qEEG change: between	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

Secondary Outcome Measures

Name	Time	Method
Time to hospital discharge (between groups)	Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.	Birth Date to NICU discharge Date
Feeding	Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.	Time to full nippled feeds prior to discharge (between groups), gathered retrospectively by chart review at NICU discharge date.
NEC/Sepsis	Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.	Episodes of necrotizing enterocolitis (NEC) and/or Sepsis (between groups), gathered retrospectively by chart review at NICU discharge date.
Duration of O2 support	Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.	Duration of supplemental O2 needs (between groups), gathered retrospectively by chart review at NICU discharge date.

Trial Locations

Locations (1)

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States