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

Not Applicable

• Conditions: Preterm Birth
• Interventions: Other: Biological Maternal Sounds

• Registration Number: NCT01913288
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-16
• Status Verified: 2013-07
• Study First Submitted QC: 2013-07-31
• Last Update Submitted: 2013-07-31
• Study First Posted: 2013-08-01
• Last Update Posted: 2013-08-01
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biological Maternal Sounds	Biological Maternal Sounds	Daily Exposure to recorded mother's voice and heartbeat sounds via audio systems installed at the bedside
Hospital Sounds	Biological Maternal Sounds	Exposure to standard hospital sounds; routine care.

Primary Outcome Measures

Name	Time	Method
Brain volume (DM^3)	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	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 Outcome Measures

Name	Time	Method
Oxygen saturation levels (mg/l)	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)	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)	Between 32-36 weeks gesation	Data will be obtained by real-time recording of the language environment
Weight gain (gr/kg/day)	participants will be followed for the duration of hospital stay, an expected average of 6 weeks	Data will be obtained from medical records

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States