Effects of Mother's Voice and Heartbeat Sounds on Preterm Newborns

July 31, 2013 updated by: Amir Lahav, Brigham and Women's Hospital

Exposure to Biological Maternal Sounds in Extremely Preterm Infants: Effects on Short- and Long-term Outcomes

The purpose of this RCT is to learn more about how sounds that we experience in the womb can affect early development in premature infants. The investigators are specifically interested determining whether and what types of maternal sensory stimulation can influence physical growth, brain maturation, respiratory stability and early vocalization during postnatal development. The investigators hypothesize that daily exposure to biological maternal sounds, such as mother's voice and heartbeat, will improve both short-term and long-term developmental in premature infants and will increase their potential to grow into healthy children.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The purpose of this RCT is to learn more about how sounds that we experience in the womb can affect early development in premature infants. The investigators are specifically interested determining whether and what types of maternal auditory stimulation can influence physical growth, brain maturation, respiratory stability (including heart rate, respiratory rate and oxygen saturation levels) as well as early vocalization prior to 40 weeks gestation. The investigators hypothesize that daily exposure to biological maternal sounds, such as mother's voice and heartbeat, will improve both short-term and long-term developmental outcomes in premature infants and will increase their potential to grow into healthy children.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:
        • Principal Investigator:
          • Amir Lahav, ScD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Born between 24-36 weeks GA.

Exclusion Criteria:

  • Chromosomal or congenital anomalies; congenital infections; > grade II IVH;
  • maternal use of tobacco, alcohol, or illicit drugs;
  • significant abuse or malnutrition during pregnancy,
  • failed ABR.
  • No exclusions based on gender or ethnicity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biological Maternal Sounds
Daily Exposure to recorded mother's voice and heartbeat sounds via audio systems installed at the bedside
Other: Biological Maternal Sounds
Sham Comparator: Hospital Sounds
Exposure to standard hospital sounds; routine care.
Other: Biological Maternal Sounds

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain volume (DM^3)
Time Frame: Between 36-40 weeks gestation
Data will be obtained by an MRI brain scan and will be calculated separately for white matter, grey matter, CSF.
Between 36-40 weeks gestation
Language and cognitive skills
Time Frame: At 12 and 24 months corrected-age
Data will be obtained using the MacArthur-Bates Communicative Development Inventories (CDI), the Receptive-Expressive Emergent Language Test Third Edition (REEL-3), and the Bayley Scales of Infant Development Third Edition (Bayley-III).
At 12 and 24 months corrected-age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen saturation levels (mg/l)
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Data will be collected from the bedside cardiac monitor
participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Heart rate (BPM)
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Data will be collected from the bedside cardiac monitor
participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Infant vocalization (word count)
Time Frame: Between 32-36 weeks gesation
Data will be obtained by real-time recording of the language environment
Between 32-36 weeks gesation
Weight gain (gr/kg/day)
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Data will be obtained from medical records
participants will be followed for the duration of hospital stay, an expected average of 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Charles H. Hood Foundation
Peter and Elizabeth C. Tower Foundation

Investigators

  • Principal Investigator: Amir Lahav, ScD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

May 16, 2013

First Submitted That Met QC Criteria

July 31, 2013

First Posted (Estimate)

August 1, 2013

Study Record Updates

Last Update Posted (Estimate)

August 1, 2013

Last Update Submitted That Met QC Criteria

July 31, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009p000936

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Preterm Birth

Clinical Trials on Biological Maternal Sounds

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe