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

Overview

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.

Full Title of Study: “Exposure to Biological Maternal Sounds in Extremely Preterm Infants: Effects on Short- and Long-term Outcomes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2018

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.

Interventions

  • Other: Biological Maternal Sounds

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Brain volume (DM^3)
    • Time Frame: Between 36-40 weeks gestation
    • Data will be obtained by an MRI brain scan and will be calculated separately for white matter, grey matter, CSF.
  • Language and cognitive skills
    • Time Frame: At 12 and 24 months corrected-age
    • 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 Measures

  • Oxygen saturation levels (mg/l)
    • Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
    • Data will be collected from the bedside cardiac monitor
  • Heart rate (BPM)
    • Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
    • Data will be collected from the bedside cardiac monitor
  • Infant vocalization (word count)
    • Time Frame: Between 32-36 weeks gesation
    • Data will be obtained by real-time recording of the language environment
  • Weight gain (gr/kg/day)
    • Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
    • Data will be obtained from medical records

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 24 Weeks

Maximum Age: 34 Weeks

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Brigham and Women’s Hospital
  • Collaborator
    • Charles H. Hood Foundation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Amir Lahav, Instructor in Pediatrics – Brigham and Women’s Hospital
  • Overall Official(s)
    • Amir Lahav, ScD, Principal Investigator, Brigham and Women’s Hospital
  • Overall Contact(s)
    • Amir Lahav, ScD, amir@hms.harvard.edu

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