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临床试验/NCT05071508
NCT05071508已完成不适用

Ability of Bedside Ultrasound to Predict and Optimize Metabolic and Neurodevelopmental Outcomes in Premature Infants in the Neonatal Intensive Care Unit

University of Minnesota1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2020年2月20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
37
试验地点
1
主要终点
Blood pressure at 4 mo

研究概览

简要总结

The objective of the project is to identify clinical factors (nutritional and non-nutritional) which are associated with ultrasound measurements of muscle and adipose tissue and to determine whether these ultrasound measurements are predictive of later metabolic and neurodevelopmental outcomes in premature infants, a population at risk for developmental delay, obesity, and metabolic disease. The investigators expect that a better understanding of these relationships will lead to the incorporation of ultrasound into routine nutritional management of preterm infants and allow for future optimization of their overall health and development.

详细描述

The specific aims are as follows:

  1. To identify clinical factors that are associated with muscle and adipose tissue measurements. The investigators will examine the relationship between clinical factors such as calorie and protein intake during hospitalization, days on parenteral nutrition, C-Reactive Protein and other clinical surrogates for inflammation and both muscle and adipose tissue measured bi-weekly using bedside ultrasound. The investigators will collect anthropometric and ultrasound measurements bi-weekly and whole body composition (utilizing ADP) data at 35 weeks postmenstrual age (PMA)/discharge from the Neonatal Intensive Care Unit. All other clinical data will be collected throughout the hospital stay.
  2. To determine whether muscle thickness and cross-sectional area are predictive of improved neurodevelopmental outcomes. The investigators will assess the relationship between ultrasound measurements of muscle with neurodevelopmental outcomes at 35 weeks PMA/discharge and 4 months corrected age. The investigators will utilize Event Related Potentials (ERP) to measure speed of processing and recognition memory as early markers of brain development.
  3. To determine whether measurements of adipose tissue are predictive of later adverse metabolic outcomes. The investigators will assess the relationship between adipose tissue thickness and blood pressure and total body adiposity (using air-displacement plethysmography) at 35 weeks PMA/discharge and 4 months corrected age.

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
25 Weeks 至 34 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • preterm infants born between 25 and 34+6 weeks gestation admitted to University of Minnesota Masonic Children's Hospital Neonatal Intensive Care Unit
  • medically stable at time of air displacement measurements

排除标准

  • infants that require medical support preventing ADP measurements from being taken

结局指标

主要结局

Blood pressure at 4 mo

时间窗: 4 months corrected age

blood pressure (systolic and diastolic)

Percent body fat inpatient

时间窗: 4 months corrected age

percent body fat (kg/kg)

Fat-free mass outpatient

时间窗: 4 months corrected age

fat-free mass (kg)

Percent body fat outpatient

时间窗: 4 months corrected age

percent body fat (kg/kg)

Ultrasound adipose measures outpatient

时间窗: 4 months corrected age

adipose tissue (cm)

Ultrasound adipose measures inpatient

时间窗: 35 weeks corrected age

adipose tissue (cm)

Ultrasound muscle measures inpatient

时间窗: 35 weeks corrected age

muscle thickness (cm)

Length data outpatient

时间窗: 4 months corrected age

length in cm

Fat mass inpatient

时间窗: 35 weeks corrected age

fat mass (kg)

ERP data inpatient

时间窗: 35 weeks corrected age

ERP paradigm

Weight data inpatient

时间窗: 35 weeks corrected age

weight in kg

Length data inpatient

时间窗: 35 weeks corrected age

length in cm

Weight data outpatient

时间窗: 4 months corrected age

weight in kg

ERP data outpatient

时间窗: 4 months corrected age

ERP paradigms

Blood pressure at 35 weeks

时间窗: 35 weeks corrected age

blood pressure (systolic and diastolic)

Fat-free mass inpatient

时间窗: 35 weeks corrected age

fat-free mass (kg)

Fat mass outpatient

时间窗: 4 months corrected age

fat mass (kg)

Ultrasound muscle measures outpatient

时间窗: 4 months corrected age

muscle measurements (cm)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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