Clinical trial NCT04193579: Listening to Mom 2: Neural, Clinical and Language Outcomes
Official title: Listening to Mom in the Neonatal Intensive Care Unit (NICU): Neural, Clinical and Language Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Premature Birth
Keywords: Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-12-10
Enrollment: 57
Sex: ALL
Minimum age (years): 24
Maximum age (years): 31
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Standard and Raw Scores of Receptive and Expressive Language on MacArthur-Bates Communicative Development Inventory (CDI): Words and Sentences
timeFrame: 18 month follow-up adjusted age for preterm birth
Secondary outcomes:
measure: White matter mean diffusivity
timeFrame: Assessed at near-term equivalent age MRI scan (approx. 36-37 weeks postmenstrual age) or at time of hospital discharge, whichever comes first
measure: Fractional Anisotropy of white matter tracts of the brain
timeFrame: Assessed at near-term equivalent age MRI scan (approx. 36-37 weeks postmenstrual age) or at time of hospital discharge, whichever comes first
measure: White matter mean diffusivity
timeFrame: Assessed at 12 month follow-up MRI
measure: Fractional Anisotropy of white matter tracts of the brain
timeFrame: Assessed at 12 month follow-up MRI
measure: Score on MacArthur-Bates Communicative Development Inventories: Words and Gestures
timeFrame: 12 month follow-up adjusted for preterm birth
measure: Number of significant apnea, bradycardia and desaturation events requiring stimulation
timeFrame: measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA
measure: Time (days) to full oral feed
timeFrame: measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA
measure: Average daily weight gain
timeFrame: measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University - Lucile Packard Children's Hospital
state: California
Study officials:
affiliation: Stanford University
name: Katherine E Travis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.