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临床试验/NCT06198478
NCT06198478已完成不适用

Tandem: Skin-to-skin Transfer From the Delivery Room to the Neonatal Unit for Neonates Above 1500 g

Erasme University Hospital1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2017年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
73
试验地点
1
主要终点
Feasibility of Skin-to-skin transfer

研究概览

简要总结

Immediate skin-to-skin contact (SSC) is already standard care for healthy term newborns, but its use for term or preterm newborns requiring admission to neonatal unit (NICU) with or without respiratory support is challenging. This study aimed to assess the safety and feasibility of SSC during the transfer of newborn infants, using a new purpose-built mobile shuttle care-station, called "Tandem".

A monocentric prospective observational study was conducted at the tertiary referral center of the Université libre de Bruxelles in Brussels, Belgium Infants born with a birth weight above 1500g were eligible. Following initial stabilization, infants were placed in SSC with one of their parents and transferred to the NICU using the Tandem.

详细描述

Prior to delivery, the trained neonatal team prepares both the Tandem and a transport incubator as a backup. Delayed umbilical cord clamping will be performed for at least one minute unless prompt resuscitation required. Then, infants will be stabilized on a resuscitation table following European Resuscitation Council guidelines, with applying electrodes for continous monitoring of heart rate, saturation and temperature. After initial stabilization respiratory support will be continued if needed using the Tandem's gas supply. In cases when, antibiotics or continuous IV glucose infusion are necessary, peripheral venous catheters will be placed before departure. In case of respiratory support, nasogastric tube will be insterted. Infants will be then transferred to the NICU under the supervision of a pediatric nurse and/or pediatrician with the Tandem in skin-to-skin position with either the mother or the father. Whenever possible, SSC will be continued for at least 120 minutes before placing the infant in an incubator. Blood glucose measurement will take place at least once during the procedure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • neonates presenting a malformation incompatible with this type of transfer
  • neonates with invasive ventilation

结局指标

主要结局

Feasibility of Skin-to-skin transfer

时间窗: 0-2 hours of life

Rate of discontinuation of the skin-to-skin was measured

次要结局

  • Safety of Skin-to-skin transfer - Oxygenisation(0-2 hours of life)
  • Safety of Skin-to-skin transfer - Hemodynamic(0-2 hours of life)
  • Parental and nursing satisfaction(0-1 days of life)
  • Breastfeeding at hospital discharge(1 day (at discharge))
  • Safety of Skin-to-skin transfer- Temperature(0-2 hours of life)
  • Safety of Skin-to-skin transfer - Blood glucose(0-2 hours of life)

研究者

发起方
Erasme University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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