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临床试验/NCT03232190
NCT03232190Unknown不适用

The Use of an Age-linked Web Application for Parents During and After a NICU Stay in Improving Child Development and Parent Empowerment

Ziekenhuis Oost-Limburg2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2014年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
180
试验地点
2
主要终点
Change in EMPO

研究概览

简要总结

The main purpose of the neonatal intensive care unit (NICU) is to optimize the development of the newborn. Preterm children are at greater risk for developmental disorders. On the one hand, this is due to cerebral complications inherent to the prematurity, on the other hand it is related to the very early and therefore vulnerable stage of brain development at the time of the premature birth. The development of the child is also the result of a constant interaction between the infant and its environment, primarily the primary caregiver (i.e. the parents). A premature birth can cause great stress to parents, and there are several obstacles that can make it difficult to handle their child. Therefore, we have developed a web application that supports parents until their child reaches the age of two. By keeping them informed, we hope to make them more confident in their role as parents, and thus facilitate the parent-child interaction. In order to determine whether this form of support has an additional effect on the development of the premature child, we compare two groups of premature infants and a group of non-premature infants.

研究设计

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

入排标准

年龄范围
— 至 32 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Premature birth (< 32 weeks)

排除标准

  • The lack of internet access or a personal email account
  • Little or no knowledge of Dutch in both parents
  • Children with a congenital disease

结局指标

主要结局

Change in EMPO

时间窗: 2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year

Dutch Empowerment Questionnaire Parental empowerment in raising children (intrapersonal, interactional, and behavioral)

WPPSI-III-NL

时间窗: 5 year

Wechsler Preschool and Primary Scale of Intelligence Cognitive Development of the Child

Change in Bayley-III-NL

时间窗: 5 months, 1 year, 2 year

Bayley Scales of Infant and Toddler Development Mental, social and motor development of the child

Change in DT-P

时间窗: 2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year

Distress Thermometer for Parents

次要结局

  • Change in PNAR(2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year)

研究者

发起方
Ziekenhuis Oost-Limburg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marie-Rose Van Hoestenberghe, MD

Neonatologist

Ziekenhuis Oost-Limburg

研究点 (2)

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