Listening to Mom in the Neonatal Intensive Care Unit (NICU): Neural, Clinical and Language Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- White matter mean diffusivity
研究概览
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. 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 24 Weeks 至 31 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born preterm at Stanford Children's Hospital between 27 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
- •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
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 (Behavioral)
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 (Behavioral)
结局指标
主要结局
White matter mean diffusivity
时间窗: 36-37 weeks post-menstrual age or at time of hospital discharge, whichever comes first
Mean diffusivity measures the average rate of water diffusion within a given MRI voxel.
次要结局
- 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)
- Length of hospital stay(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(measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA)
研究者
Katherine E Travis, PhD
Instructor
Stanford University