跳至主要内容
临床试验/NCT04983563
NCT04983563Unknown不适用

Assessment of Actigraphy in the Management of Neonatal Opioid Abstinence Syndrome of Hospitalized Newborn in Intensive Care Units

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Correlation between actigraphy and Lipsitz scoring system

研究概览

简要总结

The aim of this study is to analyse the correlation between actigraphy and Lipsitz scoring system in neonatal opioid abstinence syndrome of hospitalized newborn in intensive care units

详细描述

Hospitalized newborn in intensive care units can receive opioids to manage pain or sedation. Neonatal opioid abstinence syndrome can occur when newborn receive opioid treatment for a long time.

Many scoring systems, like Lipsitz scoring system, are used to diagnose and manage neonatal abstinence syndrome but they are subjective. The majority of items in these scores are motor skills items.

Actigraphy allows to measure objectively the newborn motricity. This study will analyse the correlation between actigraphy and Lipsitz scoring system.

研究设计

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

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Newborn > 22 gestation weeks
  • •Hospitalization in neonatal intensive care unit at CHU de Caen.
  • •Opioids treatment > 48 hours.

排除标准

  • •ante or post-natal brain injury diagnosis
  • •upper arm motor deficit
  • •palliative care

研究组 & 干预措施

Actigraphy

Experimental

干预措施: Actigraphy, eTact (Device)

结局指标

主要结局

Correlation between actigraphy and Lipsitz scoring system

时间窗: 7 days

Actigraphy and Lipsitz scoring system are realized at the same time twice a day

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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