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临床试验/NCT07045506
NCT07045506已完成不适用

Estimating Umbilical Venous Catheter Insertion Depth in Newborns Using Weight or Body Measurements: A Multicenter Randomized Clinical Trial

King Fahad Medical City2 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2022年3月8日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
184
试验地点
2
主要终点
Proportion of correctly inserted UVC at optimum catheter tip position for each method

研究概览

简要总结

Introduction: The current methods for estimating umbilical venous catheter (UVC) insertion depth, including the umbilical to nipple (Gupta) and the birth weight-based (modified Shukla) formula, have varying accuracy rates.

Objectives: To compare the accuracy of UVC insertion length using the birth weight-based formula versus the surface measurement formula in determining the optimal UVC tip position.

Methods: A multicenter randomized clinical trial was conducted in the neonatal intensive care units (NICUs) of the Second Cluster in Al Riyadh (AL Yamama Hospital and King Fahad Medical City), King Salman Armed Forces Hospital in the Northwestern Region, Tabuk City, Saudi Arabia. Neonates requiring UVC insertion during their NICU admission were randomly assigned to one of two formulas: 1) the umbilicus to nipple distance in centimeters minus 1 (UN - 1) or 2) the modified Shukla weight-based formula in centimeters (3 × birth weight in kg + 9, divided by 2) to estimate the pre-insertion UVC depth and to determine the UVC tip position anteroposterior and lateral thoracoabdominal radiographs were taken and reviewed by a neonatologist, who was blinded to the group assignments. Data analysis was conducted using appropriate statistical methods, ensuring adherence to ethical standards.

详细描述

I.Project Summary In this randomized clinical study, who are hospitalize in the neonatal intensive care unit pediatric department of King Salman Armed Forces Hospital Northwestern Region KSA Neonates who require umbilical venous catheter (UVC) insertion during their NICU admission will be randomized to one of the 2 formulas 1) umbilicus to the nipple in cm minus 1 (UN - 1) or 2) and birth weight based formula (1.5×birth weight (Kg) + 5.6) for estimation of the pre-insertion UVC depth. UVC will be inserted under sterile condition as per our unit protocol. Then to determine the UVC tip position, anteroposterior and lateral a thoracoabdominal radiograph will be taken.

II.Introduction Umbilical vessel catheterization of newborns was used for more than 60 years (1,2).The ideal position of UVC tip to decrease complications is outside the heart at the junction of inferior vena cava and right atrium (3). UVC related complications are mainly due to catheter malposition as pericardial effusions , cardiac tamponade and cardiac thrombus have been reported with UVCs whose tips lay within the heart (4). There is no definite rule describe how far umbilical catheters should be inserted in the umbilical vein; different methods including the Dunn method, Shukla-Ferrara, modified Shukla-Ferrara and umbilicus to the nipple formulae are used (5). Selection of the most correct methods is very important in terms of decreasing th risk and frequency of complications (6,7). IN KFMC NICU and Alyamah NICU and Pediatric department of King Salman Armed Forces Hospital Northwestern Region KSA , the most commonly used method for estimation of UVC insertion length is the birth weight based formula (3× birth weight (Kg) +9)/2. A recent retrospective study reported that 57% accuracy rate with birth weight based formula(8). In our units no audit done for accuracy rate of UVC dependent on birth weight based formula endpoint

The endpoint measurement of UVC tip determined by anteroposterior x ray (12,13) to check where is the tipe of UVC located that is used in our unit

III.Project Objectives

Research Questions: Does the estimating insertion depth using umbilicus to the nipple in cm minus 1 (UN - 1) formula more accurate than a birth weight-derived formula resulted in more correctly placed umbilical venues catheters.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
— 至 1 Week(Child)
性别
All
接受健康志愿者

入选标准

  • All neonates who require UVC insertion as part of their intensive care during their NICU admission

排除标准

  • Any neonate where the UVC is medically contra-indicated like lower limb ischemia, omphalitis, umbilical bleeding, confirmed intra-vascular thrombosis or DIC.
  • Neonates with hydrops fetalis, abdominal wall defects, congenital diaphragmatic hernia, major congenital heart disease, and declined to participate or insertion of UVC beyand one week .

结局指标

主要结局

Proportion of correctly inserted UVC at optimum catheter tip position for each method

时间窗: Within 48 Hours

Proportion of correctly inserted UVC at optimum catheter tip position for each method

时间窗: Within 48 Hours

次要结局

未报告次要终点

研究者

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

Fawzy Kamel Abdelhamid

Consultant Neonatology

King Fahad Medical City

研究点 (2)

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