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

Primary Purpose

Preterm Birth

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Biological Maternal Sounds

About this trial

This is an interventional treatment trial for Preterm Birth focused on measuring neonatal care, preterm, maternal sounds, auditory stimulation

Eligibility Criteria

24 Weeks - 34 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Brigham and Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Biological Maternal Sounds

Hospital Sounds

Arm Description

Daily Exposure to recorded mother's voice and heartbeat sounds via audio systems installed at the bedside

Exposure to standard hospital sounds; routine care.

Outcomes

Primary Outcome Measures

Brain volume (DM^3)

Data will be obtained by an MRI brain scan and will be calculated separately for white matter, grey matter, CSF.

Language and cognitive skills

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).

Secondary Outcome Measures

Oxygen saturation levels (mg/l)

Data will be collected from the bedside cardiac monitor

Heart rate (BPM)

Data will be collected from the bedside cardiac monitor

Infant vocalization (word count)

Data will be obtained by real-time recording of the language environment

Weight gain (gr/kg/day)

Data will be obtained from medical records

Full Information

NCT ID

NCT01913288

First Posted

May 16, 2013

Last Updated

July 31, 2013

Sponsor

Brigham and Women's Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01913288

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Unknown status

Study Start Date

May 2013 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brigham and Women's Hospital

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preterm Birth

Keywords

neonatal care, preterm, maternal sounds, auditory stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Biological Maternal Sounds

Arm Type

Experimental

Arm Description

Daily Exposure to recorded mother's voice and heartbeat sounds via audio systems installed at the bedside

Arm Title

Hospital Sounds

Arm Type

Sham Comparator

Arm Description

Exposure to standard hospital sounds; routine care.

Intervention Type

Other

Intervention Name(s)

Biological Maternal Sounds

Primary Outcome Measure Information:

Title

Brain volume (DM^3)

Description

Data will be obtained by an MRI brain scan and will be calculated separately for white matter, grey matter, CSF.

Time Frame

Between 36-40 weeks gestation

Title

Language and cognitive skills

Description

Time Frame

At 12 and 24 months corrected-age

Secondary Outcome Measure Information:

Title

Oxygen saturation levels (mg/l)

Description

Data will be collected from the bedside cardiac monitor

Time Frame

participants will be followed for the duration of hospital stay, an expected average of 6 weeks

Title

Heart rate (BPM)

Description

Data will be collected from the bedside cardiac monitor

Time Frame

participants will be followed for the duration of hospital stay, an expected average of 6 weeks

Title

Infant vocalization (word count)

Description

Data will be obtained by real-time recording of the language environment

Time Frame

Between 32-36 weeks gesation

Title

Weight gain (gr/kg/day)

Description

Data will be obtained from medical records

Time Frame

participants will be followed for the duration of hospital stay, an expected average of 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

24 Weeks

Maximum Age & Unit of Time

34 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amir Lahav, ScD

amir@hms.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amir Lahav, ScD

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul Hughes

phughes@partners.org

First Name & Middle Initial & Last Name & Degree

Amir Lahav, ScD

12. IPD Sharing Statement

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

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