Listening to Mom 2: Neural, Clinical and Language Outcomes

Not Applicable

Active, not recruiting

• Conditions: Premature Birth
• Interventions: Behavioral: Language Treatment; Behavioral: Control Treatment

• Registration Number: NCT04193579
• Lead Sponsor: Stanford University

Brief 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.

Study Timeline

• Study Start: 2019-11-25
• Study First Submitted: 2019-12-06
• Study First Submitted QC: 2019-12-06
• Study First Posted: 2019-12-10
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21
• Primary Completion: 2025-08-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Infants born preterm at Stanford Children's Hospital between 24 0/7 - 31 6/7 weeks gestational age

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Exclusion Criteria

• Congenital anomalies
• Recognizable malformation syndromes
• Active seizure disorders
• History of Central Nervous System infections
• Hydrocephalus
• Major sensori-neural hearing loss
• Likelihood to be transferred from NICU to alternate care facility or home environment prior to 36 weeks PMA and/or brain MRI scan
• Intraventricular Hemorrhage Grades III-IV
• Cystic periventricular leukomalacia (PVL)
• Surgical treatment for necrotizing enterocolitis
• Small for gestational age (SGA) <3 percentile and/or Intra-uterine growth restriction (IUGR) no head sparing
• Twin-to-twin transfusions

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Language Treatment Arm	Language Treatment	An infant participant randomized to the language treatment arm will be played recordings of his/her mother's voice 2-3 hours daily in the intermediate care nursery until discharge.
Control Treatment Arm	Control Treatment	An infant participant randomized to the control treatment arm will receive standard of care. Standard of care does not include being played recordings of his/her mother's voice while admitted to the intermediate care nursery. However, an infant randomized to the control treatment will have the same auditory equipment placed in his/her isolette or crib as an infant randomized to the Language Treatment Arm.

Primary Outcome Measures

Name	Time	Method
Standard and Raw Scores of Receptive and Expressive Language on MacArthur-Bates Communicative Development Inventory (CDI): Words and Sentences	18 month follow-up adjusted age for preterm birth	Parent questionnaire of receptive and expressive language skills. Will be used to assess the long-term impact of intervention on language outcomes. Standard scores are based on percentiles for age and sex and range from \<1 to 99th percentile. Raw scores range from 0 to 680. Both higher standard scores and raw scores indicate better performance.

Secondary Outcome Measures

Name	Time	Method
White matter mean diffusivity	Assessed at 12 month follow-up MRI	Diffusion MRI metric that measures the average rate of water diffusion. It is used to assess white matter development and structure
Average daily weight gain	measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA	measured as weight gain per day
Number of significant apnea, bradycardia and desaturation events requiring stimulation	measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA	Reflects degree of cardiorespiratory stability
Fractional Anisotropy of white matter tracts of the brain	Assessed at 12 month follow-up MRI	Diffusion MRI metric that measures the directionality of water diffusion in the brain. It is used to assess white matter development and structure.
Score on MacArthur-Bates Communicative Development Inventories: Words and Gestures	12 month follow-up adjusted for preterm birth	Parent questionnaire of receptive and expressive language skills. Will be used to assess the long-term impact of intervention on language outcomes. Standard scores are based on percentiles for age and sex and range from \<1 to 99th percentile. Raw scores range from 0 to 396. Both higher standard scores and raw scores indicate better performance.
Time (days) to full oral feed	measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA	days until 100 % of nutrition administered orally

Trial Locations

Locations (1)

Stanford University - Lucile Packard Children's Hospital; 🇺🇸 Palo Alto, California, United States