Listening to Mom in the NICU: Neural, Clinical and Language Outcomes

Study Overview
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Brief Summary
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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
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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. Participation in this study requires that all infants receive up to an additional 10 minutes of brain scans as part of his/her routine clinical magnetic resonance imaging (MRI).

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

Conditions
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Premature Birth

Intervention / Treatment
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* Behavioral: Language Treatment
* Behavioral: Control Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants born preterm at Stanford Children's Hospital between 27 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 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

Ages Eligible for Study
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Minimum Age: 24 Weeks
Maximum Age: 31 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Language Treatment Arm<br>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<br>* Recording of a mother's voice reading a children's storybook.<br>|
| Sham Comparator: Control Treatment Arm<br>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<br>* Standard of Care<br>* Other names: Standard of Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| White matter mean diffusivity | Mean diffusivity measures the average rate of water diffusion within a given MRI voxel. | 36-37 weeks post-menstrual age or at time of hospital discharge, whichever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Days in hospital since birth and until discharge | Days in hospital since birth and until discharge, average range is 37-40 weeks postmenstrual age (PMA) | 
| Average daily weight gain |  | 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 | 
| Number of significant apnea and bradycardia events requiring stimulation |  | measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature Birth, Obstetric Labor, Premature, Obstetric Labor Complications, Pregnancy Complications