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

NCT ID: NCT01913288

Last Updated: 2013-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Preterm Birth

Keywords

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neonatal care, preterm, maternal sounds, auditory stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Biological Maternal Sounds

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

Group Type EXPERIMENTAL

Biological Maternal Sounds

Intervention Type OTHER

Hospital Sounds

Exposure to standard hospital sounds; routine care.

Group Type SHAM_COMPARATOR

Biological Maternal Sounds

Intervention Type OTHER

Interventions

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Biological Maternal Sounds

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

24 Weeks

Maximum Eligible Age

34 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charles H. Hood Foundation

OTHER

Sponsor Role collaborator

Peter and Elizabeth C. Tower Foundation

UNKNOWN

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Amir Lahav

Instructor in Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amir Lahav, ScD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amir Lahav, ScD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Paul Hughes

Role: primary

Other Identifiers

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2009p000936

Identifier Type: -

Identifier Source: org_study_id