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Behavioral Intervention
Maternal Voice Recording for Premature Infants
N/A
Waitlist Available
Led By Dawn Novak, MD
Research Sponsored by University of New Mexico
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
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.
Awards & highlights
Study Summary
This trial looks at whether recorded maternal voice has an effect on premature infants' brain development, as measured by EEG.
Who is the study for?
This trial is for premature infants born between 28 and 32 weeks gestation, with mothers who can provide a voice recording in English. Infants with serious heart defects, genetic disorders, metabolic errors, neurological issues or on certain medications are excluded. Mothers under 18 or unable to consent are also not eligible.Check my eligibility
What is being tested?
The study tests the effect of recorded maternal voices versus placebo recordings on brain development markers in preterm infants using qEEG. It's a short-term randomized trial where neither the participants nor the researchers know which recording each infant receives.See study design
What are the potential side effects?
Since this trial involves listening to recordings without any medication or invasive procedures, there aren't typical side effects associated with it as seen in drug trials.
Timeline
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.
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Who is running the clinical trial?
University of New MexicoLead Sponsor
372 Previous Clinical Trials
3,528,749 Total Patients Enrolled
4 Trials studying Premature Birth
127 Patients Enrolled for Premature Birth
Dawn Novak, MDPrincipal InvestigatorUniversity of New Mexico, Health Sciences Center
Aaron Cardon, MDStudy ChairUniversity of New Mexico, Health Sciences Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My infant is on medication for epilepsy or sedation before an EEG.My mother cannot provide a voice recording in English.My child is in foster care, will be adopted, or is a ward of the state.My baby was born between 28 and 32 weeks of pregnancy.My mother can speak and read English and is available to provide a voice recording.My infant has a diagnosed brain disorder or abnormality.My infant has a serious heart condition present at birth.My infant has a genetic disorder.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Recorded Voice Exposure
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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Does this treatment program have an age limit?
"This study is only for patients that 28 and 33 weeks old."
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