跳至主要内容
临床试验/CTRI/2025/11/097606
CTRI/2025/11/097606尚未招募不适用

A RANDOMISED CONTROL TRIAL TO ESTIMATE THE UMBILICAL VENOUS CATHETER INSERTION DEPTH IN NEWBORNS USING BIRTH WEIGHT VERSUS SHOULDER UMBILICAL LENGTH

Dr Uma S Belvanki1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年11月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
180
试验地点
1
主要终点
Proportion of neonates with optimal umbilical venous catheter tip position at the inferior vena cava- right atrial junction, confirmed by chest X-ray

研究概览

简要总结

Accurate placement of umbilical venous catheter in neonates is crucial to ensure effective delivery of fluids, medications and parenteral nutrition.  The optimal UVC tip position is at the inferior vena cava- right atrial junction. However predicting the appropriate insertion length remains challenging and different methods are in clinical use. 2 commonly practiced techniques are birth weight based formula ( Shukla and Ferrara formula) and shoulder umbilical length measurement (Dunns method). Both methods are widely used but have variable accuracy. This randomised control Trial aims to compare the accuracy of these 2 methods for estimating UVC insertion depth. Eligible neonates requiring UVC will be randomised in a 1:1 ratio to either birth weight based method or shoulder umbilical length method. In both group, calculated insertion length will be used during catherization and the tip position will be confirmed by Chest X ray. The primary outcome will be the proportion of neonates with catheter tip correctly positioned at the inferior vena cava - right atrial junction . Secondary outcomes include malpositions, catheter related complications, dwell time. This study will provide evidence regarding relative accuracy and safety of 2 commonly used methods for UVC insertion length estimation, with potential to inform Neonatal Intensive care practice and improve patient outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
0.00 Day(s) 至 2.00 Day(s)(—)
性别
All

入选标准

  • All preterm and term neonates requiring umbilical vein catheterization in KIMS NICU.

排除标准

  • Neonates with congenital anomalies like omphalocele, umbilical sepsis, congenital diaphragmatic hernia, necrotising enterocolitis.

结局指标

主要结局

Proportion of neonates with optimal umbilical venous catheter tip position at the inferior vena cava- right atrial junction, confirmed by chest X-ray

时间窗: Within 1 hour of insertion

次要结局

  • Malposition rate ( hepatic vein, right atrium or other malpositions) confirmed on X ray(Within 24 hours of insertion)
  • Complications related to UVC insertion ( Arrhythmia, bleeding, perforation, thrombosis, infection )(Up to 7 days post insertion)
  • Duration of catheter dwell and reason for removal(At catheter removal)

研究者

发起方
Dr Uma S Belvanki
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Uma S Belvanki

Kempegowda Institute of Medical Sciences

研究点 (1)

Loading locations...

相似试验