跳至主要内容
临床试验/NCT03171844
NCT03171844已完成不适用

Early Skin to Skin in Neonatal reanimation_Risk Assessment in the Newborn With an Umbilical Venous Catheter

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年5月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Bacteremia

研究概览

简要总结

In the reanimation neonatal department of the Nice's hospital, 34% of newborns admitted have an umbilical vein catheter (KTVO). Their parents are admitted 24h/24h by their side, where everything is done to set up the Attachment (participation in care, skin to skin, support of breastfeeding, ...).

The benefits of skin to skin described in developmental care of the newborn in the neonatal health services are well established. Nevertheless, for supposed risks (infectious and displacement of the catheter), registered in the memory of the teams, this care is not currently carried out when the newborns are carrying an umbilical venous catheter.

Sometimes, because of the presence of an umbilical venous catheter, parents and their newborns could not enjoy this moment of well-being in the first days of life. We therefore propose a study evaluating the current risks of skin to skin with an umbilical venous catheter by reflecting on a new protocol for laying and fixing this medical device.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Newborn of gestational age less than 37SA
  • •Admitted in neonatal reanimation department at Nice's hospital
  • •Born in the maternity ward of the Nice's hospital
  • •Carriers of an umbilical venous catheter.

排除标准

  • •All newborns with medical contraindications from skin to skin:
  • •Controlled hypothermia protocol
  • •Newborn under HFO (High Frequency Oscillation)
  • •Carrying a diaphragmatic hernia
  • •Thoracic drain holder
  • •With major PAH (hypertensive pulmonary artery)
  • •Symptomatic mother of acute infectious disease
  • •Mother whose physical or psychiatric capacity is not compatible with travel to the neonatal reanimation service within 3 days of delivery.
  • •Minor mother

研究组 & 干预措施

Skin to skin

Experimental

Implement of skin to skin

干预措施: Skin to skin (Other)

结局指标

主要结局

Bacteremia

时间窗: 48h

Occurrence of a bacterial blood infection concomitant with Umbilical venous catheter and up to 48 hours after its withdrawal

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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