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临床试验/NCT00222456
NCT00222456已完成不适用

Can Early Intervention Prevent Developmental Disturbances/Delays and Improve the Health of Children Born Prematurely

University Hospital of North Norway2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 1999年3月1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
210
试验地点
2
主要终点
Cognitive and behavioral outcome

研究概览

简要总结

The purpose of this study is to examine whether an early intervention program may improve cognitive and behavioral short and longterm outcome in preterm infants.

详细描述

Advances in neonatal medicine has increased the survival of infants with low birth weight. Repeatedly it has been documented an increased prevalence of psychological and medical problems in this group of children. Frequent psychological problems are intellectual disturbances, language delays, behavior problems like ADHD and learning difficulties. Usual medical problems are subnormal growth, various illnesses and neuro-developmental problems.

The high prevalence of psychological and medical risks makes this group of children target for follow-up assessments and early intervention.

The main aim of the project is to investigate whether sensitizing the parents will reduce the incidence of developmental disturbances in a group of low birth weight infants compared to a control group.

The study is carried out as a cooperation between the Departments of child- and adolescent psychiatry and pediatrics of the University Hospital in Tromsoe in Northern - Norway. 140 premature infants with birth weight less than 2000 grams are randomly distributed to an intervention and control group. In addition 70 full term infants are selected to another control.

A slightly modified version of The Vermont Intervention Program for Low Birth Weight Infants is applied to the infants in the intervention group, where the parents receive one hour of instruction from a special trained neonatal nurse one hour per day the last week before discharge (infant = 37 weeks G.A.). In addition, the parents receive four home visits during the the three first months after discharge.

研究设计

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

入排标准

年龄范围
0 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Birth weight < 2000 gram

排除标准

  • Congenital anomalies
  • Non-Norwegian speaking mother

结局指标

主要结局

Cognitive and behavioral outcome

Parenting Stress

次要结局

  • Neurodevelopmental outcome

研究者

发起方
University Hospital of North Norway
申办方类型
Other

研究点 (2)

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