Behavioral Intervention
Recorded Maternal Voice for Premature Birth
University of New Mexico, Albuquerque, NM
Targeting 3 different conditionsRecorded Maternal Voice +1 moreN/AWaitlist AvailableLed by Dawn Novak, MDResearch Sponsored by University of New MexicoEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Must not have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upapproximately 7-10 weeks, at nicu discharge date which typically occures around post-conceptional age 39-42 weeks.
Awards & highlights
Study Summary
This trial looks at whether recorded maternal voice has an effect on premature infants' brain development, as measured by EEG.
Eligible Conditions
- Premature Birth
- Premature Infants
- Developmental Delay
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 7-10 weeks, at nicu discharge date which typically occures around post-conceptional age 39-42 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 7-10 weeks, at nicu discharge date which typically occures around post-conceptional age 39-42 weeks.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
qEEG change: between
qEEG change: within
Secondary outcome measures
Duration of O2 support
Feeding
Septicemia
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Recorded Voice ExposureExperimental Treatment1 Intervention
Starting at 33 0/7 weeks corrected gestational age (regardless of birth gestation), infants randomized to the intervention arm will be played a recording of their mother's voice with approximately 60 minutes of scripted content, once per 24 hours for a 2-week (14 day) intervention period. (Mothers will be recorded reading a children's book and the recording will be looped to create the 60 minutes of content).
Group II: PlaceboPlacebo Group1 Intervention
Starting at 33 0/7 weeks corrected gestational age (regardless of birth gestation), infants randomized to the non-intervention arm will be played a blank recording of approximately 60 minutes duration, once every 24 hours for a 2-week (14 day) period.
Find a site
Who is running the clinical trial?
University of New MexicoLead Sponsor
357 Previous Clinical Trials
3,527,272 Total Patients Enrolled
4 Trials studying Premature Birth
127 Patients Enrolled for Premature Birth
Dawn Novak, MDPrincipal Investigator
University of New Mexico, Health Sciences CenterAaron Cardon, MDStudy Chair
University of New Mexico, Health Sciences CenterMeghan GroghanStudy Director
University of New Mexico, Health Sciences CenterMedia Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do we have any new participants for this experiment?
"Unfortunately, this specific trial is not currently enrolling patients. Although, according to the latest information from clinicaltrials.gov, this may change in the future as the trial was first posted on 2/15/2022 and was most recently edited on 5/20/2022. Additionally, there are 301 other trials that are actively looking for participants."
Answered by AI
Does this treatment program have an age limit?
"This study is only for patients that 28 and 33 weeks old."
Answered by AI