Recorded Maternal Voice for Premature Birth

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of New Mexico, Albuquerque, NM
Premature Birth+2 More
Recorded Maternal Voice - Behavioral
Eligibility
< 18
All Sexes
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Study 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.

Eligible Conditions

  • Premature Birth
  • Infants, Premature
  • Development Delay

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.

2 weeks
qEEG change: between
qEEG change: within
Week 42
Duration of O2 support
Feeding
NEC/Sepsis
Time to hospital discharge (between groups)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Recorded Voice Exposure
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: Recorded Maternal Voice · Has Placebo Group · N/A

Recorded Voice Exposure
Behavioral
Experimental Group · 1 Intervention: Recorded Maternal Voice · Intervention Types: Behavioral
Placebo
Behavioral
PlaceboComparator Group · 1 Intervention: Placebo Recording · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 7-10 weeks, at nicu discharge date which typically occures around post-conceptional age 39-42 weeks.
Closest Location: University of New Mexico · Albuquerque, NM
Photo of new mexico 1Photo of new mexico 2Photo of new mexico 3
1992First Recorded Clinical Trial
17 TrialsResearching Premature Birth
233 CompletedClinical Trials

Who is running the clinical trial?

University of New MexicoLead Sponsor
333 Previous Clinical Trials
3,536,153 Total Patients Enrolled
4 Trials studying Premature Birth
235 Patients Enrolled for Premature Birth
Aaron Cardon, MDStudy ChairUniversity of New Mexico, Health Sciences Center
Dawn Novak, MDPrincipal InvestigatorUniversity of New Mexico, Health Sciences Center
Meghan GroghanStudy DirectorUniversity of New Mexico, Health Sciences Center

Eligibility Criteria

Age < 18 · All Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.