Ultrasound Screening for Developmental Dysplasia of the Hip in the Neonate: The Effect on Treatment Rate and Prevalence of Late Cases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11,925
- 试验地点
- 2
- 主要终点
- prevalence of DDH detected after newborn period
研究概览
简要总结
The aim of the randomized controlled trial was to determine whether the addition of a general or of a selective ultrasound screening program resulted in more appropriate criteria for treatment and a reduced prevalence of late DDH compared with clinical examination alone.
详细描述
This is a retrospective registration of a RCT carried out in 1988-90, with a IRB approved follow-up at skeletal maturity carried out in 2007-09. Both the RCT and the follow-up study were carried out in the same institution, by the same PI (Prof. Karen Rosendahl) and her co-workers.
Detailed information is published in the following paper:
Rosendahl K, Markestad T, Lie RT. Ultrasound screening for developmental dysplasia of the hip in the neonate: the effect on treatment rate and prevalence of late cases. Pediatrics 1994;94:47-52.
A sample of the initial RCT was invited for a maturity review/follow-up at skeletal maturity.
The follow-up at skeletal maturity is called:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- — 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all babies born at our institution during 1/1988-06/1990
排除标准
- •low birthweight <1500 grams, severe malformations, death within first month
研究组 & 干预措施
expert clinical exam only
all babies assigned to this group had expert clinical examination only, no hip ultrasound
干预措施: hip ultrasound (Procedure)
selective hip ultrasound screening
all children classified at increased risk, based on clinical findings and/or risk factors (breech presentation, family history, foot deformity)received a hip ultrasound at birth, in addition to expert clinical screening
干预措施: hip ultrasound (Procedure)
universal hip ultrasound screening
All newborns assigned to this arm received hip ultrasound at birth in addition to expert clinical examination
干预措施: hip ultrasound (Procedure)
结局指标
主要结局
prevalence of DDH detected after newborn period
时间窗: 20 years
prevalence of late cases of DDH, detected after newborn period (after first month of age, including in childhood as assessed in original RCT during 1988-90, with a minimum follow-up time of 27 months, and also at skeletal maturity, as assessed in follow-up study during 2007-09.
次要结局
- treatment rate(20 years)
研究者
Lene Bjerke Laborie
MD, Phd
University of Bergen