Listening to Mom 2: Neural, Clinical and Language Outcomes

Listening to Mom in the Neonatal Intensive Care Unit (NICU): 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Premature Birth
• Intervention / Treatment: Behavioral: Language Treatment; Behavioral: Control Treatment

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 Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine E Travis, PhD; Phone Number: 650-498-7690; Email: ktravis1@stanford.edu
• Study Contact Backup: Name: Edith Brignoni-Perez, PhD; Phone Number: 650-498-7690; Email: edithbp@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University - Lucile Packard Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Language Treatment Arm; 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; Recording of a mother's voice reading a children's storybook.
Sham Comparator: Control Treatment Arm; 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; Standard of Care; Other Names: Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
White matter mean diffusivity	Diffusion MRI metric that measures the average rate of water diffusion. It is used to assess white matter development and structure.	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	Diffusion MRI metric that measures the directionality of water diffusion in the brain. It is used to assess white matter development and structure.	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	Diffusion MRI metric that measures the average rate of water diffusion. It is used to assess white matter development and structure	Assessed at 12 month follow-up MRI
Fractional Anisotropy of white matter tracts of the brain	Diffusion MRI metric that measures the directionality of water diffusion in the brain. It is used to assess white matter development and structure.	Assessed at 12 month follow-up MRI
Score on MacArthur-Bates Communicative Development Inventories: Words and Gestures	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.	12 month follow-up adjusted for preterm birth
Number of significant apnea, bradycardia and desaturation events requiring stimulation	Reflects degree of cardiorespiratory stability	measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA
Time (days) to full oral feed	days until 100 % of nutrition administered orally	measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA
Average daily weight gain	measured as weight gain per day	measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Katherine E Travis, PhD, Stanford University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2019
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: December 6, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Pregnancy Complications; Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: 32638-2; 1K99HD084749-01A1 (U.S. NIH Grant/Contract); R00HD084749 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No