Clinical trial NCT02847689: Listening to Mom in the NICU: 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: COMPLETED
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: 2016-07-28
Enrollment: 46
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. 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).

Eligibility criteria: 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

Primary outcomes:
measure: White matter mean diffusivity
timeFrame: 36-37 weeks post-menstrual age or at time of hospital discharge, whichever comes first
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Days in hospital since birth and until discharge, average range is 37-40 weeks postmenstrual age (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
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: Number of significant apnea and bradycardia events requiring stimulation
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: