Maternal Voice and Quantitative EEG (qEEG)

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05391633
• Other study ID #: 21-417
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: May 2023
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: November 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks to 33 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Development Delay
• Premature Birth
• Prematurity

Intervention

Behavioral:
• Recorded Maternal Voice
60-minute looped recording of maternal voice, played once daily for 14 total days.
• Placebo Recording
60-minute blank recording played once daily for 14 total days.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	qEEG change: within	Change in relative spectral power, within group, of alpha (8-13 Hz) and beta (14-20 Hz) band	2 weeks
Primary	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	2 weeks
Secondary	Time to hospital discharge (between groups)	Birth Date to NICU discharge Date	Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.
Secondary	Feeding	Time to full nippled feeds prior to discharge (between groups), gathered retrospectively by chart review at NICU discharge date.	Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.
Secondary	NEC/Sepsis	Episodes of necrotizing enterocolitis (NEC) and/or Sepsis (between groups), gathered retrospectively by chart review at NICU discharge date.	Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.
Secondary	Duration of O2 support	Duration of supplemental O2 needs (between groups), gathered retrospectively by chart review at NICU discharge date.	Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.