Listening to Mom 2: Neural, Clinical and Language Outcomes

NCT04193579 | Completed DMC

• 3 other identifiers: 32638-21K99HD084749-01A1R00HD084749
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Keywords

Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications

Outcome Measures

Primary Outcomes (1)

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

  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.

  18 month follow-up adjusted age for preterm birth

Secondary Outcomes (8)

• White matter mean diffusivity

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

• Fractional Anisotropy of white matter tracts of the brain

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

• White matter mean diffusivity

  Assessed at 12 month follow-up MRI

• Fractional Anisotropy of white matter tracts of the brain

  Assessed at 12 month follow-up MRI

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

  12 month follow-up adjusted for preterm birth

Study Arms (2)

Language Treatment Arm

EXPERIMENTAL

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.

Behavioral: Language Treatment

Control Treatment Arm

SHAM COMPARATOR

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.

Behavioral: Control Treatment

Interventions

Language Treatment BEHAVIORAL

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

Language Treatment Arm

Control Treatment BEHAVIORAL

Standard of Care

Also known as: Standard of Care

Control Treatment Arm

Eligibility Criteria

• Age: 24 Weeks - 31 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Stanford University - Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• Brignoni-Perez E, Morales MC, Marchman VA, Scala M, Feldman HM, Yeom K, Travis KE. Listening to Mom in the NICU: effects of increased maternal speech exposure on language outcomes and white matter development in infants born very preterm. Trials. 2021 Jul 13;22(1):444. doi: 10.1186/s13063-021-05385-4.

  PMID: 34256820 DERIVED

MeSH Terms

Conditions

Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Katherine E Travis, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 10, 2019
• Study Start: November 25, 2019
• Primary Completion: April 26, 2025
• Study Completion: April 26, 2025
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)