Clinical trial NCT05391633: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prematurity
Development Delay
Premature Birth
Keywords: quantitative EEG
Spectral Density Analysis
At Risk for Cognitive Delay
Premature Birth 28-32 weeks gestation
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 40
Sex: ALL
Minimum age (years): 28
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Crossed design, between-group and within-group pre- and post-intervention changes in primary variable.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: qEEG change: within
timeFrame: 2 weeks
measure: qEEG change: between
timeFrame: 2 weeks
Secondary outcomes:
measure: Time to hospital discharge (between groups)
timeFrame: Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.
measure: Feeding
timeFrame: Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.
measure: NEC/Sepsis
timeFrame: Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.
measure: Duration of O2 support
timeFrame: Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico, Health Sciences Center
name: Aaron Cardon, MD
role: STUDY_CHAIR
affiliation: University of New Mexico, Health Sciences Center
name: Dawn Novak, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of New Mexico, Health Sciences Center
name: Meghan Groghan
role: STUDY_DIRECTOR
References: