Stopped: Per PI, enrollment stopped due to a lack of continued funding and staffing
United States14 participantsStarted 2022-02-15
Plain-language 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.
Who can participate
Age range28 Weeks – 33 Weeks
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …