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临床试验/NCT01599780
NCT01599780已完成不适用

On- and Off-line Measures of Language Development in Preterm Children

Stanford University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
The Looking-While-Listening Task

研究概览

简要总结

This research investigates the ways in which preterm birth affects how very young children learn to speak and understand language, and how older children gain efficiency in language processing. The investigators observe how children at different ages learn new words and comprehend familiar words, how they communicate effectively with others, and how they use both linguistic and non-linguistic skills in problem-solving. All of the activities in the investigators' studies are designed to be age-appropriate and fun for children.

详细描述

In a typical session, the investigators video-record your child participating in one or more engaging activities with you and/or a member of the staff.

  • In one type of task, your child looks at colorful pictures on a video screen while listening to recorded speech referring to the pictures. The investigators may vary factors in the speech stimuli such as word familiarity or sentence structure to learn more about the development of language understanding. Your child is seated on your lap throughout the session. From the video record, the investigators can later look at your child's gaze patterns in response to speech.
  • In another type of task, the investigators observe children interacting with a staff member in the playroom. In these game-like activities, your child may be asked to play with toys, name or point to pictures, repeat sequences of words or sentences, tell stories, imitate hand movements, or solve puzzles. These observations help the investigators understand how language development relates to other types of cognitive activities in children at different ages.
  • In a third type of task, the investigators observe how children interact spontaneously in a less structured situation. In some cases, the investigators observe you as you play with your child in a playroom. The investigators will provide you with a selection of toys appropriate to your child's age, and ask you to engage with your child as you would at home. From these observations, the investigators learn how children at different ages respond to language in the context of social interaction.

The investigators may also collect a language questionnaire and similar forms containing basic information about your child's development. Additionally, the investigators may review your child's medical records, including ultrasounds and MRI scans, to gain a better understanding of your child's medical history. All information is used for purposes of basic research on language learning only, and will not constitute a clinical assessment or evaluation.

TIME INVOLVEMENT

In this longitudinal study, each child is expected to come for a total of 12-16 sessions of behavioral testing, spread out over 3 years. Children are tested in 2 sessions (sessions occur approximately one week apart) at ages 18 (chronological), 18 (adjusted; applicable to pre-terms), 24, 30, 36, 42, 48, and 54 months. Each session typically lasts from 30 to 60 minutes, depending on the age of the child and number of breaks taken.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
— 至 18 Months(Child)
性别
All
接受健康志愿者

入选标准

  • <33 weeks gestation
  • <1800 grams at birth
  • currently ≤ 18 months

排除标准

  • an active seizure disorder (afebrile seizure within the last year) and/or anticonvulsant medication use
  • central nervous system infections, revisions or other complications of a ventriculoperitoneal shunt for treatment for hydrocephalus, and/or congenital malformations
  • history of a sensori-neural hearing loss, defined as 4-tone pure-tone average > 25 decibels
  • visual impairments

结局指标

主要结局

The Looking-While-Listening Task

时间窗: 18 months, 18 months adjusted, 24 months, 30 months, & 36 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heidi M. Feldman

Professor

Stanford University

研究点 (1)

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Language Development in Preterm Children | 临床试验