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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
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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
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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
No

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
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).
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
No
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
Email
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
Email
phughes@partners.org
First Name & Middle Initial & Last Name & Degree
Amir Lahav, ScD

12. IPD Sharing Statement

Learn more about this trial

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

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