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临床试验/CTRI/2018/11/016329
CTRI/2018/11/016329招募中4 期

Comparison of UVC with PICC line insertion as a primary central line for reducing late onset sepsis in preterm infants with birth weight less than 1250grams: A randomised control trail

FH Educational and Research Foundation1 个研究点 分布在 1 个国家目标入组 338 人开始时间: 2018年11月14日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
338
试验地点
1
主要终点
Late Onset Sepsis

研究概览

简要总结

In this RCT we are comparing UVC with PICC to reduce the incidence of late onset sepsis in preterm infants with birth weight <1250grams. Only infants requiring central line and admitted to the neonatal unit would be recruited in this trail. UVC would be inserted with the tip just above the diaphragm and PICC would be inserted either in the upper limp or in the lower limb with the tip either at SVC to right atrium junction or in the IVC respectively. Late Onset sepsis (blood culture positive) with onset 48 hours after line insertion till 48 hours after line removal would be primary outcome of this study. Probable sepsis, line insertion related complication and survival till discharge would be the secondary outcomes. Inability to insert the line on two attempts or removal of line due to malposition or immediate complication would be considered as a failure. UVC would be removed at day 10 or earlier if not clinically indicated whereas PICC would be removed at any time clinical indication is not required. 154 infants would be enrolled in PICC group and 184 infants in UVC group assuming 25% LOS in UVC group and 15% in the PICC group with an alpha error of 5% and Power of 80% and assumed failure rate of 20% in UVC group. This would a RCT with computer generated random numbers and stratified for birth weight <1000 grams and 1000 to 1249 grams.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
0.00 Day(s) 至 30.00 Day(s)(—)
性别
All

入选标准

  • All preterm infants with birth weight <1250grams and eligible for a central line placement.

排除标准

  • Those with major malformations, maternal chorioamnionits.

结局指标

主要结局

Late Onset Sepsis

时间窗: 48 hours from insertion to 48 hours after removal of Central line

次要结局

  • Malposition of lIne,Thrombophlebilits, Local Infections, bleeding at site insertion, failure rates, survival, DIC, probable sepsis, Thrombus formation(till discharge of the neonate from the unit)

研究者

发起方
FH Educational and Research Foundation
申办方类型
Research institution and hospital

研究点 (1)

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