NCT04193579

Listening to Mom 2: Neural, Clinical and Language Outcomes

Listening to Mom in the Neonatal Intensive Care Unit (NICU): Neural, Clinical and Language Outcomes

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 24 Weeks – 31 Weeks
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine whether playing recordings of a mother's voice to her infant while in the hospital nursery is an effective treatment for promoting healthy brain and language development in infants born preterm.

Detailed description

Children born preterm are at-risk for developmental language delays. Language problems in preterm children are thought to be related to neurobiological factors, including injuries to white matter structures of the brain and environmental factors, including decreased exposure to maternal speech in the hospital nursery. There is evidence to suggest that maternal speech input may be important for promoting healthy brain and language development. Participants will be randomly assigned to one of two study groups. Each infant has a 50% chance of being assigned to the group that will listen to a recording of his/her mother's voice and a 50% chance of being assigned to the group that will not be played a voice recording. Mother's of participating infants will have her voice recorded as she reads a common children's storybook. Recordings will be played to infants each day until s/he is discharged from the hospital. To assess the long term impacts of this treatment, research participants and their families will be asked to return for follow-up visiting to perform an MRI brain scan and complete questionnaires and test that assess language development. Follow-up visit occur when infants are between 12 to 18 months of age.

Conditions

• Premature Birth

Interventions

Type	Name	Description
BEHAVIORAL	Language Treatment	Recording of a mother's voice reading a children's storybook.
BEHAVIORAL	Control Treatment	Standard of Care

Timeline

• Start date: 2019-11-25
• Primary completion: 2025-08-01
• Completion: 2026-03-01
• First posted: 2019-12-10
• Last updated: 2025-05-15

Locations

1 site across 1 country: United States