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临床试验/NCT05496400
NCT05496400已完成不适用

Effect of Anemia of Prematurity and Its Treatment on Hemodynamics of Preterm Infants

Marwa Mohamed Farag1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
1. Cardiac output:

研究概览

简要总结

The aim of this work to study the hemodynamic changes accompanying anemia of prematurity in neonates with gestational age ≤32 weeks and the effect of its treatment on hemodynamics.

详细描述

This prospective observational study aims to evaluate the hemodynamic changes provoked by anemia of prematurity and transfusion of packed red blood cells (RBCs). Nonanemic inpatient premature infants (Hematocrit>30%) will be compared with pretransfusional anemic inpatient premature infants. Anemic premature infants will be assessed before and 24 hours after the transfusion of pRBCs. Cerebral, intestinal and renal blood flow velocities, cardiac output parameters will be measured in premature neonates who will fulfill the eligibility criteria of the study.This study will be conducted at the neonatal intensive care units in Alexandria University Hospitals.

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
3 Weeks 至 6 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm infants ≤32 weeks gestational age, regardless their weight with postnatal age 3-6 weeks.

排除标准

  • 未提供

结局指标

主要结局

1. Cardiac output:

时间窗: 3-6 weeks postnatal age

Probe: GE 12S-RS probe with a frequency range of 5 - 11 MHz. Cardiac output as the product of stroke volume and heart rate: actual body weight in mL/kg/min; Stroke volume (the product of velocity time integral at the level of aortic valve pulsed wave (PW) and cross-sectional area of the left ventricular outflow tract at the level of aortic valve using 2D.(

2. Cerebral blood flow velocities

时间窗: 3-6 weeks postnatal age

in the anterior cerebral artery through the anterior fontanelle in the sagittal plane

4.Renal blood flow velocities

时间窗: 3-6 weeks postnatal age

Renal blood flow velocities in the right renal artery by placing the transducer below the right costal arch in the dorsolateral area of the flank in longitudinal axis.

3. Intestinal blood flow velocities

时间窗: 3-6 weeks postnatal age

in the celiac artery from a longitudinal abdominal section, determined close to the origin of the artery from the abdominal aorta.

次要结局

未报告次要终点

研究者

发起方
Marwa Mohamed Farag
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Marwa Mohamed Farag

Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine

Alexandria University

研究点 (1)

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