Listening to Mom 2: Neural, Clinical and Language Outcomes

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04193579
• Other study ID #: 32638-2
• Secondary ID: 1K99HD084749-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 25, 2019
• Est. completion date: March 1, 2026

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 57
• Est. completion date: March 1, 2026
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks to 31 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

Behavioral:
• Language Treatment
Recording of a mother's voice reading a children's storybook.
• Control Treatment
Standard of Care

Locations

Country	Name	City	State
United States	Stanford University - Lucile Packard Children's Hospital	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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