Recruiting

Maternal Sounds

Sponsor:

Brigham and Women's Hospital

Code:

NCT01913288

Conditions

Preterm Birth

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Biological Maternal Sounds

Study Details

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

Study ID

NCT01913288

Start date

May, 2013

Status verified date

Jul, 2013

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Biological Maternal Sounds

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

sham comparator: Hospital Sounds

Exposure to standard hospital sounds; routine care.

Interventions

Biological Maternal Sounds

Primary outcome measure

  • Brain volume (DM^3) [ Time Frame: Between 36-40 weeks gestation ]
  • Language and cognitive skills [ Time Frame: At 12 and 24 months corrected-age ]

Central Contacts and Locations

Central contacts

Amir Lahav, ScD

amir@hms.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Paul Hughes

phughes@partners.org

Principal Investigator:

Amir Lahav, ScD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Aug 1, 2013

Last verified

Jul, 2013

Keywords

  • neonatal care, preterm, maternal sounds, auditory stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2013-08-01.