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临床试验/NCT03522558
NCT03522558Unknown不适用

Medical Nutrition Therapy for Medically Complex Infants in the Pediatric Outpatient Setting. A Quality Improvement Project

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
2
主要终点
Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)

研究概览

简要总结

The purpose of this study is to compare standardized nutrition therapy provided by a registered dietitian (RD) at regularly scheduled intervals to usual care in terms of the ability to improve growth parameters in medically complex infants in the pediatric outpatient setting.

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
Single (Outcomes Assessor)

入排标准

年龄范围
— 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients who are admitted between July, 2018 and June, 2019 to the Neonatal High-Risk Clinic (NHRC) and High Risk Children's Clinic (HRCC) at UT Health from a neonatal intensive care unit (NICU)

排除标准

  • short bowel syndrome,
  • requiring parenteral nutrition (PN)
  • active cancer

结局指标

主要结局

Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)

时间窗: 1 year corrected gestational age (CGA)

次要结局

  • Length of stay(about 3 to 7 days)
  • Severity of malnutrition as assessed by the AND/ASPEN criteria(1 year corrected gestational age (CGA))
  • Number of participants with growth failure(1 year corrected gestational age (CGA))
  • Number of participants who are malnourished(1 year corrected gestational age (CGA))
  • Number of emergency department visits(1 year corrected gestational age (CGA))
  • Number of hospitalizations(1 year corrected gestational age (CGA))

研究者

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

Candice Rachel Poland

Registered Dietitian

The University of Texas Health Science Center, Houston

研究点 (2)

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