Listening to Mom in the Neonatal Intensive Care Unit (NICU): Neural, Clinical and Language Outcomes
概览
- 阶段
- 不适用
- 干预措施
- Language Treatment
- 疾病 / 适应症
- Premature Birth
- 发起方
- Stanford University
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Standard and Raw Scores of Receptive and Expressive Language on MacArthur-Bates Communicative Development Inventory (CDI): Words and Sentences
- 状态
- 已完成
- 最后更新
- 8天前
概览
简要总结
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.
详细描述
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.
研究者
Katherine E Travis, PhD
Assistant Professor
Stanford University
入排标准
入选标准
- •Infants born preterm at Stanford Children's Hospital between 24 0/7 - 31 6/7 weeks gestational age
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Language Treatment
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.
干预措施: Control Treatment
结局指标
主要结局
Standard and Raw Scores of Receptive and Expressive Language on MacArthur-Bates Communicative Development Inventory (CDI): Words and Sentences
时间窗: 18 month follow-up adjusted age for preterm birth
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.
次要结局
- White matter mean diffusivity(Assessed at 12 month follow-up MRI)
- Average daily weight gain(measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA)
- Number of significant apnea, bradycardia and desaturation events requiring stimulation(measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA)
- Fractional Anisotropy of white matter tracts of the brain(Assessed at 12 month follow-up MRI)
- Score on MacArthur-Bates Communicative Development Inventories: Words and Gestures(12 month follow-up adjusted for preterm birth)
- Time (days) to full oral feed(measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA)
- White matter mean diffusivity(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(Assessed at near-term equivalent age MRI scan (approx. 36-37 weeks postmenstrual age) or at time of hospital discharge, whichever comes first)