Apply to Trial

Compensation: Varies

Number of Visits: 3

40 Participants Needed

Maternal Voice Recording for Premature Infants

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of New Mexico

Must not be taking: Antiepileptics, Sedatives

Disqualifiers: Cardiac disease, Neurologic disorder, others

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to participate in the trial?

The trial does not specify whether participants need to stop taking their current medications. However, infants receiving antiepileptic or sedation medications before the EEG are excluded from the trial.

What data supports the effectiveness of the treatment Placebo Recording, Recorded Maternal Voice for premature infants?

Research shows that listening to a recorded maternal voice can help stabilize preterm infants by reducing cardiorespiratory events and improving feeding behaviors, which are important for their development and health.¹ ² ³ ⁴ ⁵

How is the treatment of recorded maternal voice unique for premature infants?

The treatment of recorded maternal voice is unique because it uses the mother's voice to potentially improve feeding, growth, and neural development in premature infants, unlike other treatments that may not focus on auditory stimulation. This approach leverages the familiar and comforting sound of the mother's voice to positively influence the infant's physiological and developmental outcomes.¹ ⁴ ⁶ ⁷ ⁸

Research Team

Aaron Cardon, MD

Principal Investigator

University of New Mexico, Health Sciences Center

Dawn Novak, MD

Principal Investigator

University of New Mexico, Health Sciences Center

Meghan Groghan

Principal Investigator

University of New Mexico, Health Sciences Center

Eligibility Criteria

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.

Inclusion Criteria

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.

Exclusion 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.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline EEG

Initial EEG of 60-90 minutes duration performed at 32 5/7 - 32 6/7 weeks

1 week

1 visit (in-person)

Intervention

Infants receive either recorded maternal voice or placebo for 2 weeks

2 weeks

Daily sessions

Post-intervention EEG

Second EEG of 30-60 minutes duration performed between 35 0/7 - 35 6/7 weeks

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment until NICU discharge

Approximately 7-10 weeks

Treatment Details

Interventions

Placebo Recording
Recorded Maternal Voice

Trial OverviewThe 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.

Participant Groups

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.