Maternal Voice and Quantitative EEG (qEEG)

Sponsor

University of New Mexico (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05391633

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prematurity Development Delay Premature Birth	Behavioral: Recorded Maternal Voice Behavioral: Placebo Recording	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Investigator, Outcomes 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.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 15, 2022

Anticipated Primary Completion Date :

Nov 15, 2022

Anticipated Study Completion Date :

Nov 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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.	Behavioral: Placebo Recording 60-minute blank recording played once daily for 14 total days.
Experimental: 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).	Behavioral: Recorded Maternal Voice 60-minute looped recording of maternal voice, played once daily for 14 total days.

Arm

Intervention/Treatment

Placebo Comparator: 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.

Behavioral: Placebo Recording

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

Experimental: 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).

Behavioral: Recorded Maternal Voice

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

28 Weeks to 33 Weeks

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of New Mexico	Albuquerque	New Mexico	United States	87131

Sponsors and Collaborators

University of New Mexico

Investigators

Study Chair: Aaron Cardon, MD, University of New Mexico, Health Sciences Center
Principal Investigator: Dawn Novak, MD, University of New Mexico, Health Sciences Center
Study Director: Meghan Groghan, University of New Mexico, Health Sciences Center