Status:
TERMINATED
Maternal Voice and Quantitative EEG (qEEG)
Lead Sponsor:
University of New Mexico
Conditions:
Prematurity
Development Delay
Eligibility:
All Genders
28-33 years
Phase:
NA
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 quantitat...
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 con...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05391633
Start Date
February 15 2022
End Date
June 12 2024
Last Update
September 15 2025
Active Locations (1)
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1
University of New Mexico
Albuquerque, New Mexico, United States, 87131