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Maternal Voice and Quantitative EEG (qEEG)

Primary Purpose

Prematurity, Development Delay, Premature Birth

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Recorded Maternal Voice

Placebo Recording

About this trial

This is an interventional prevention trial for Prematurity focused on measuring quantitative EEG, Spectral Density Analysis, At Risk for Cognitive Delay, Premature Birth 28-32 weeks gestation

Eligibility Criteria

28 Weeks - 33 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of New Mexico

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Recorded Voice Exposure

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

qEEG change: within

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

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

Secondary Outcome Measures

Time to hospital discharge (between groups)

Birth Date to NICU discharge Date

Feeding

Time to full nippled feeds prior to discharge (between groups), gathered retrospectively by chart review at NICU discharge date.

NEC/Sepsis

Episodes of necrotizing enterocolitis (NEC) and/or Sepsis (between groups), gathered retrospectively by chart review at NICU discharge date.

Duration of O2 support

Duration of supplemental O2 needs (between groups), gathered retrospectively by chart review at NICU discharge date.

Full Information

NCT ID

NCT05391633

First Posted

February 15, 2022

Last Updated

May 15, 2023

Sponsor

University of New Mexico

1. Study Identification

Unique Protocol Identification Number

NCT05391633

Brief Title

Maternal Voice and Quantitative EEG (qEEG)

Official Title

Effect of Recorded Maternal Voice on Quantitative EEG (qEEG) as a Marker for Developmental Risk in the Preterm Newborn

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

February 15, 2022 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of New Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prematurity, Development Delay, Premature Birth

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

InvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

Recorded Voice Exposure

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Recorded Maternal Voice

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Placebo Recording

Intervention Description

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

Primary Outcome Measure Information:

Title

qEEG change: within

Description

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

Time Frame

2 weeks

Title

qEEG change: between

Description

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 Outcome Measure Information:

Title

Time to hospital discharge (between groups)

Description

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.

Title

Feeding

Description

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.

Title

NEC/Sepsis

Description

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.

Title

Duration of O2 support

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

28 Weeks

Maximum Age & Unit of Time

33 Weeks

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aaron Cardon, MD

Organizational Affiliation

University of New Mexico, Health Sciences Center

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Dawn Novak, MD

Organizational Affiliation

University of New Mexico, Health Sciences Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Meghan Groghan

Organizational Affiliation

University of New Mexico, Health Sciences Center

Official's Role

Study Director

Facility Information:

Facility Name

University of New Mexico

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87131

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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