Maternal Voice and Quantitative EEG (qEEG)

University of New Mexico14 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Prematurity Development Delay Premature Birth

Interventions

Recorded Maternal VoiceBEHAVIORAL

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

Placebo RecordingBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 28 WeeksMax age: 33 Weeks

Medical Language ↔ Plain English

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

Locations (1)

University of New Mexico

Albuquerque, New Mexico, United States

Outcomes

Primary Outcomes

qEEG change: within

Change in relative spectral power, within group, of alpha (8-13 Hz) and beta (14-20 Hz) band

Time frame: 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

Time frame: 2 weeks

Secondary Outcomes

Time to hospital discharge (between groups)

Birth Date to NICU discharge Date

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

Data from ClinicalTrials.gov

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