Effect of Recorded Maternal Voice on Quantitative EEG (qEEG) as a Marker for Developmental Risk in the Preterm Newborn
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prematurity
- Sponsor
- University of New Mexico
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- qEEG change: within
- Status
- Terminated
- Last Updated
- 7 months ago
Overview
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.
Investigators
Aaron Cardon
Assistant Professor of Neurology
University of New Mexico
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
Outcomes
Primary Outcomes
qEEG change: within
Time Frame: 2 weeks
Change in relative spectral power, within group, of alpha (8-13 Hz) and beta (14-20 Hz) band
qEEG change: between
Time Frame: 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 Outcomes
- Time to hospital discharge (between groups)(Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.)
- Feeding(Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.)
- NEC/Sepsis(Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.)
- Duration of O2 support(Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.)