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Completed

NCT Number: NCT04193579

Listening to Mom 2: Neural, Clinical and Language Outcomes

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.

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Key information

Age range

24 week–31 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University - Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Language Treatment

Behavioral

Recording of a mother's voice reading a children's storybook.

Control treatment

Behavioral

Standard of Care

Other names: Standard of Care

Primary outcomes

  1. Standard and Raw Scores of Receptive and Expressive Language on MacArthur-Bates Communicative Development Inventory (CDI): Words and Sentences

    Time frame: 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 outcomes

  1. White matter mean diffusivity

    Time frame: Assessed at near-term equivalent age MRI scan (approx. 36-37 weeks postmenstrual age) or at time of hospital discharge, whichever comes first

    Diffusion MRI metric that measures the average rate of water diffusion. It is used to assess white matter development and structure.

  2. Fractional Anisotropy of white matter tracts of the brain

    Time frame: Assessed at near-term equivalent age MRI scan (approx. 36-37 weeks postmenstrual age) or at time of hospital discharge, whichever comes first

    Diffusion MRI metric that measures the directionality of water diffusion in the brain. It is used to assess white matter development and structure.

  3. White matter mean diffusivity

    Time frame: 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

  4. Fractional Anisotropy of white matter tracts of the brain

    Time frame: 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.

  5. Score on MacArthur-Bates Communicative Development Inventories: Words and Gestures

    Time frame: 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.

  6. Number of significant apnea, bradycardia and desaturation events requiring stimulation

    Time frame: measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA

    Reflects degree of cardiorespiratory stability

  7. Time (days) to full oral feed

    Time frame: 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

  8. Average daily weight gain

    Time frame: measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA

    measured as weight gain per day

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2019
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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