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

Preterm Birth Clinical Trial

Official title:

Exposure to Biological Maternal Sounds in Extremely Preterm Infants: Effects on Short- and Long-term Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01913288
• Other study ID #: 2009p000936
• Status: Recruiting
• Phase: N/A
• First received: May 16, 2013
• Last updated: July 31, 2013
• Start date: May 2013
• Est. completion date: December 2019

Study information

• Verified date: July 2013
• Source: Brigham and Women's Hospital
• Contact: Amir Lahav, ScD
• Email: amir[@]hms.harvard.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Weeks to 34 Weeks

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Other:
• Biological Maternal Sounds

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Charles H. Hood Foundation, Peter and Elizabeth C. Tower Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Oxygen saturation levels (mg/l)	Data will be collected from the bedside cardiac monitor	participants will be followed for the duration of hospital stay, an expected average of 6 weeks	No
Secondary	Heart rate (BPM)	Data will be collected from the bedside cardiac monitor	participants will be followed for the duration of hospital stay, an expected average of 6 weeks	No
Secondary	Infant vocalization (word count)	Data will be obtained by real-time recording of the language environment	Between 32-36 weeks gesation	No
Secondary	Weight gain (gr/kg/day)	Data will be obtained from medical records	participants will be followed for the duration of hospital stay, an expected average of 6 weeks	No