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 Mexico

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 below

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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 7-10 weeks, at nicu discharge date which typically occures around post-conceptional age 39-42 weeks. for reporting.

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 more

Trial 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 Center
Aaron Cardon, MDStudy Chair
University of New Mexico, Health Sciences Center
Meghan GroghanStudy Director
University of New Mexico, Health Sciences Center

Media Library

Recorded Maternal Voice (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05391633 — N/A
Premature Birth Research Study Groups: Recorded Voice Exposure, Placebo
Premature Birth Clinical Trial 2023: Recorded Maternal Voice Highlights & Side Effects. Trial Name: NCT05391633 — N/A
Recorded Maternal Voice (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05391633 — N/A

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
~13 spots leftby Jun 2024