Clinical trial NCT01913288: Effects of Mother's Voice and Heartbeat Sounds on Preterm Newborns
Official title: Exposure to Biological Maternal Sounds in Extremely Preterm Infants: Effects on Short- and Long-term Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Birth
Keywords: neonatal care, preterm, maternal sounds, auditory stimulation
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Charles H. Hood Foundation
name: Peter and Elizabeth C. Tower Foundation
First posted: 2013-08-01
Enrollment: 150
Sex: ALL
Minimum age (years): 24
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Brain volume (DM^3)
timeFrame: Between 36-40 weeks gestation
measure: Language and cognitive skills
timeFrame: At 12 and 24 months corrected-age
Secondary outcomes:
measure: Oxygen saturation levels (mg/l)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
measure: Heart rate (BPM)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
measure: Infant vocalization (word count)
timeFrame: Between 32-36 weeks gesation
measure: Weight gain (gr/kg/day)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Amir Lahav, ScD
role: PRINCIPAL_INVESTIGATOR
References: