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

NCT01913288 | Unknown

• 1 other identifier: 2009p000936
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Keywords

neonatal care, preterm, maternal sounds, auditory stimulation

Outcome Measures

Primary Outcomes (2)

• Brain volume (DM^3)

  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

  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 Outcomes (4)

• Oxygen saturation levels (mg/l)

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

• Heart rate (BPM)

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

• Infant vocalization (word count)

  Between 32-36 weeks gesation

• Weight gain (gr/kg/day)

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

Study Arms (2)

Biological Maternal Sounds

EXPERIMENTAL

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

Other: Biological Maternal Sounds

Hospital Sounds

SHAM COMPARATOR

Exposure to standard hospital sounds; routine care.

Other: Biological Maternal Sounds

Interventions

Biological Maternal Sounds OTHER

Biological Maternal Sounds; Hospital Sounds

Eligibility Criteria

• Age: 24 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Born between 24-36 weeks GA.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Charles H. Hood Foundation: collaborator
• Peter and Elizabeth C. Tower Foundation: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Amir Lahav, ScD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amir Lahav, ScD

CONTACT

amir@hms.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Pediatrics

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: August 1, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: August 1, 2013

Record last verified: 2013-07

Locations

US (1)