Follow-up of Extreme Neonatal Hyperbilirubinemia in 5-10 Year Old Children: a Danish Population Based Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 主要终点
- Motor development
研究概览
简要总结
The objective of this study was to investigate whether infants with total serum bilirubin > 450 umol/L in the neonatal period and no symptoms or no more than early acute bilirubin encephalopathy develop long term sequelae with impairment of motor development, hearing and executive function compared with a control group.
详细描述
Children in both the exposed and the non-exposed group were examined by use of the MABC-2 and pure tone audiometry by the responsible examiner for the study, Pernille Vandborg, MD. The aim was to see whether the exposed group suffered any long term sequelae to the extreme neonatal hyperbilirubinemia, i.e. impaired motor development or hearing impairment, compared to a control group. The examinations took place at the local hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age > 35 weeks
- •Total serum bilirubin > 450 umol/L in the neonatal period
- •Born in the period 01.01.2000 - 31.12.2005
排除标准
- •Acute intermediate or advanced bilirubin encephalopathy
结局指标
主要结局
Motor development
时间窗: Age 5-10 years
Delayed motor development for children in the exposed group compared to children in the non-exposed group
次要结局
未报告次要终点