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临床试验/CTRI/2022/09/045696
CTRI/2022/09/045696已完成不适用

CEREBRAL BLOOD FLOW VELOCITY IN NEONATES AT RISK OF POLYCYTHEMIA AND ITS CORRELATION TO HEAMATOCRIT

RAINBOW CHILDRENS HOSPITAL1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年9月25日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
to correlate PSV of ACA, MCA with hematocrit with neonate at risk of polycthemia

研究概览

简要总结

incidence of polycythemia is 1.5 to 45 of all live births. diagnosis of polycythemia requires venous hematocrit which is invasive. polycythemia is associated with altered cerebral hemodynamics. our efforts are to ascertain cerbral blood flow parameters in polycythemic babies for possible future implementation in clinical practice. .our objective is to correlate PSV of anterior and middle cerebral artery with hematocrit in neonates at risk of polycythemia. secondary objective is to compare cerebral blood flow velocity, RI in neonates with polycythemia and normocythemia. ours is a prospective observational study, babies with gestational age of more than 35weeks having risk factors of polycythemia will be enrolled in the study. free flow venous blood is sent for hematocrit measurement between 2 and 6 hours of life. repeat PCV is sent in the babies with prior value of PCV more than 65% at 36hrs of life /before discharge. PSV end diastolic velocity RI of MCA and ACA will be measured using Mindray portable ultrasound machine. with minicurved usg transducer. (8-13MHZ)

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 1.00 Day(s)(—)
性别
All

入选标准

  • neonates with gestational age more than 35 weeks and having one or more risk factors for polycythemia which includes SGA, LGA, IDM, Post maturity, gestational hypertension, large twin of monochorionic twin.

排除标准

  • sick neonates requiring NICU admission, in whom consent is denied.

结局指标

主要结局

to correlate PSV of ACA, MCA with hematocrit with neonate at risk of polycthemia

时间窗: PSV measured between 2 and 6 hour of life and one more time before discharge / after 36 hours of life | 1st Haematocrit measured between 2 and 6 hour of life, subsequent Haematocrit measured after 36 hours/before discharge if Initial measured Haemotocrit is more than 65%

次要结局

  • to compare cerebral blood flow velocity, RI in neonates with polcythemia and normocythemia(Cerebral blood flow velocity RI measured initially between 2 and 6 hour of life and subsequently after 36 hours of life/ before discharge)

研究者

申办方类型
Private hospital/clinic

研究点 (1)

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