跳至主要内容
临床试验/NCT03977545
NCT03977545Unknown不适用

Assessment of Actigraphy in the Management of Neonatal Opioid Abstinence Syndrome

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年1月23日最近更新:
适应症

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 our study is to analyse the correlation between actigraphy and Lipsitz scoring system in neonatal opioid abstinence syndrome.

详细描述

Neonatal opioid abstinence syndrome occurs after birth when opioids were used by the mother during pregnancy.

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. We will analyse the correlation between actigraphy and Lipsitz scoring system in four groups of newborns.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
— 至 1 Day(Child)
性别
All
接受健康志愿者

入选标准

  • Newborn > 32 weeks of gestation + 0 day

排除标准

  • perinatal asphyxia
  • 5- minute Apgar score < 7
  • ante or post-natal brain injury diagnosis
  • upper arm motor deficit
  • hospitalization in intensive care unit
  • neonatal respiratory distress

结局指标

主要结局

Correlation between actigraphy and Lipsitz scoring system

时间窗: ninety minutes after feeding

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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