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

Mass General Brigham

Status: Unknown

Conditions: Preterm Birth

Treatments: Other: Biological Maternal Sounds

Study type: Interventional

Funder types: Other

Identifiers

NCT01913288

2009p000936

Details and patient eligibility

About

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 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 24 to 34 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Biological Maternal Sounds

Experimental group

Description:

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

Treatment:

Other: Biological Maternal Sounds

Hospital Sounds

Sham Comparator group

Description:

Exposure to standard hospital sounds; routine care.

Treatment:

Other: Biological Maternal Sounds