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临床试验/NCT03373539
NCT03373539已完成不适用

Neurotrophin Expression in Infants as a Predictor of Respiratory and Neurodevelopmental Outcomes

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2014年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Correlation of serum neurotrophins with development for Bronchopulmonary Dysplasia

研究概览

简要总结

Important developmental processes continue until the completion of 40 weeks gestation. Even during fetal life, intrinsic and environmental factors determine the balance between health and the onset and development of diseases. Thus, it is crucial to understand the mechanisms that regulate normal development and the pathways that contribute to disease pathogenesis.

Neurotrophins are a family of four proteins that support the growth and survival of neurons. Their secretion increases during brain development, when new neurons are being formed and existing ones are branching to assemble complex neuronal circuits. In addition to their role in promoting neuron growth and development, neurotrophins are also a product of neuronal activity. Neurotrophins are also responsible for the maintenance of peripheral sensory neurons, including those in the lungs. Airway innervation is responsible for many aspects of lung function including the regulation of airway smooth muscle tone, mucus secretion, and reactivity; therefore, a physiological expression of neurotrophins in the lungs is required for normal lung function.

详细描述

Currently, there is no reliable method to identify infants who will have poor neurodevelopmental and respiratory outcomes. The ability to make such predictions would be beneficial for both making care decisions in the neonatal intensive care unit and for identifying infants who require earlier and more intense intervention. We intend to determine if neurotrophins can be utilized to predict an infant's long-term outcomes. Neurotrophins are a family of four proteins that support the growth and survival of neurons. Their levels have been shown to increase with brain development and decrease with brain injury. Neurotrophins have also been associated with development of airway injury in the neonate and later respiratory disease such as asthma. We plan to correlate serum neurotrophin levels with respiratory outcomes and neurological outcomes.

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
1 Day 至 4 Months(Child)
性别
All
接受健康志愿者

入选标准

  • intubated infants in the Neonatal Intensive Care Unit (NICU)

排除标准

  • unwilling or unable to give or obtain informed consent

结局指标

主要结局

Correlation of serum neurotrophins with development for Bronchopulmonary Dysplasia

时间窗: within 48 hours of Neonatal Intensive Care Unit admission

Neurotrophins include Nerve Growth Factor (NGF) and Brain-factor Neurotrophic Factor (BDNF)

Change in serum neurotrophins with developmental delays in children

时间窗: Within 48 hours of Neonatal Intensive Care Unit admission, at 4 months, 1 year and 2 years

Neurotrophins include Nerve Growth Factor (NGF) and Brain-factor Neurotrophic Factor (BDNF)

Change in serum neurotrophins with respiratory outcomes in children

时间窗: Within 48 hours of Neonatal Intensive Care Unit admission, at 4 months, 1 year and 2 years

Neurotrophins include Nerve Growth Factor (NGF) and Brain-factor Neurotrophic Factor (BDNF)

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

Fariba Rezaee

Staff

The Cleveland Clinic

研究点 (1)

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