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临床试验/NCT02725814
NCT02725814已完成不适用

Sucrose Practices for Pain in Neonates Part B: Efficacy of Repeated Sucrose Administration, Infant Response to Administration, and Effect on Outcomes

The Hospital for Sick Children10 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
172
试验地点
10
主要终点
Neurodevelopment (vision, hearing, speech, emotion, dexterity, self-care, cognition, pain, general health and behaviour)

研究概览

简要总结

Recent studies show that babies in hospital undergo an average of 4 to 5 painful procedures, such as heel lances, every day. Sucrose (sugar water) has been shown to be effective for reducing babies' pain during painful procedures. Unfortunately, sucrose is not used as often as it could be to reduce babies' pain. This may be due to lack of certainty about the least effective amount of sucrose to use and concerns about the long-term effects of repeated use of sucrose on infant development. Factors within the hospital units where babies receive care may also influence caregivers' decisions to use sucrose. In this research the investigators will conduct two main studies. In the first study the investigators determined the lowest amount of sucrose needed to manage babies' pain effectively. In the second study the investigators will explore (a) if this amount of sucrose can manage pain when it is used repeatedly for all painful procedures while the baby is hospitalized and (b) whether consistent use of sucrose influences the development of babies when they are 18 and 36 months old. During the second study, the investigators will also examine the hospital units where the babies receive care. They will look at staff support for research, time and resources and other factors that promote and prevent sucrose use. The results of these studies will be used to determine the best management of babies' pain during painful procedures in hospitals to achieve the best outcomes.

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

年龄范围
— 至 10 Days(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Neurodevelopment (vision, hearing, speech, emotion, dexterity, self-care, cognition, pain, general health and behaviour)

时间窗: 36 months corrected gestational age

Assessed by the Health Status Classification System-Preschool (HSCS-PS)

Pain intensity

时间窗: Measured 60 seconds post-painful procedure. (NB: Enrolled infants may be evaluated for multiple painful procedures.)

Assessed by the Premature Infant Pain Profile - Revised (PIPP-R)

Neurodevelopment (cognitive, language and motor development)

时间窗: 36 months corrected gestational age

Assessed by the Bayley Scales of Infant and Toddler Development (BSITD-III)

Neurodevelopment (social-emotional functioning)

时间窗: 36 months corrected gestational age

Assessed by the Ages \& Stages Questionnaires: Social-Emotional, Second Edition (ASQ:SE-2)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bonnie Stevens

Associate Chief of Nursing Research, Senior Scientist

The Hospital for Sick Children

研究点 (10)

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