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临床试验/NCT03246243
NCT03246243终止不适用

Quantitative Assessment of Sucking for Early Diagnosis of Brain Injury in Infants at High Risk

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2017年3月29日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
16
试验地点
1
主要终点
Difference in sucking activity of infants with brain injury

研究概览

简要总结

The main goal of this study is to quantitatively assess the sucking and feeding activity of infants at high risk of neurological impairment (preterm infants and term infants at risk of abnormal neurodevelopment) during oral sucking and feeding and correlate it with their underlying neurological impairment for the early diagnosis of brain injury.

详细描述

This research will address the current lack of objective tools for the reliable assessment of oral sucking and feeding in clinical practice, and the insufficient evidence that relates early measures of abnormal sucking activity with the underlying neurological impairment.

The main goal of this study is to quantitatively assess the sucking and feeding activity of infants at high risk of neurological impairment (preterm infants and term infants at risk of abnormal neurodevelopment) during oral sucking and feeding and correlate it with their underlying neurological impairment for the early diagnosis of brain injury. We aim to study three groups of infants who are inpatients on the Neonatal Intensive Care Unit (NICU) at Boston Children's Hospital (BCH), the NICU or Newborn Nursery at Beth Israel Deaconess Medical Center (BIDMC), the Special Care Nursery (SCN) or Newborn Nursery at Winchester Hospital as follows: (i) group A consisting of preterm infants (gestational age of <37 weeks), (ii) group B consisting of term infants admitted to the NICU at BCH and BIDMC for therapeutic hypothermia who are at risk of developing hypoxic ischemic injury (HIE); admitted with concern for neonatal stroke; seizures of unknown etiology; and those admitted to the NICU, SCN or Newborn Nursery at BCH, BIDMC and Winchester Hospital at risk of abnormal neurodevelopment such as those with hypoglycemia or neonatal abstinence syndrome (NAS) and; (iii) group C consisting of healthy term infants admitted to the NICU, SCN or nursery who had an initial uncomplicated postnatal course that will serve as the control group. Additionally, those infants who have MRI of the brain for any reason during the course of their hospital admission will also be included in the study and allocated to the appropriate group accordingly.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm infants with GA<37 weeks
  • Term infants with GA>37 weeks and at risk of brain injury
  • Healthy term infants with GA= 37-41 weeks, appropriate birth weight, 5 minute Apgar score>7, and an initial uncomplicated postnatal course

排除标准

  • major congenital anomalies
  • craniofacial malformation
  • short bowel syndrome

结局指标

主要结局

Difference in sucking activity of infants with brain injury

时间窗: Approximately one year through study completion

Primary outcome will be an assessment of the sucking activity of infants with brain injury and infants without brain injury, using an FDA-approved device for sucking assessment.

次要结局

  • Sucking activity of infants and brain connectivity(Approximately three years through study completion)

研究者

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

Christos Papadelis

PhD

Boston Children's Hospital

研究点 (1)

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