Effectiveness of a Prenatal Educational Intervention to Prevent Positional Occipital Plagiocephaly: a Randomized Multicenter Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Difference in the ODDI index measured with a craniometer
研究概览
简要总结
Positional occipital plagiocephaly (POP) is a morphological abnormality of the cranium which, in the absence of early synostosis of the cranial sutures, is caused by external forces acting on the skull, which is highly malleable in newborns. The most common form of POP is the "acquired" type, which manifests around 2-3 months of age and reaches its peak severity around 4 months. The incidence of POP is 46.6% at 7-12 weeks of life, and 78.3% of cases are mild severity. In addition to being an aesthetic problem, POP can alter the first phase of a child's postural-motor development, causing postural asymmetries in the neck or spine, or asymmetries in the functional motor skills. Often, attention is only paid to the condition at a later stage, when the situation is very evident and often associated with other issues, resulting in longer, more expensive physiotherapy treatments and poorer outcomes.
Recently, interest has emerged in the possibility of preventing POP: studies have been conducted showing that preventive and educational intervention with families on the most appropriate ways of caring for their babies after birth effectively reduces the incidence and severity of POP in the first months of life and that good nationwide training of healthcare professionals on this topic could help minimize public healthcare costs.
The Specialist Interest Group (GIS) in Pediatric Physiotherapy of the AIFI Italian Association of Physiotherapists (AIFI) has produced a brochure for parents on the prevention of POP.
Primary endpoint: to assess whether the educational intervention for the prevention of POP carried out by the physiotherapist, as part of the prenatal program, reduces the incidence of POP in infants at 3 months of age.
Secondary endpoints: to assess whether the educational intervention is effective in preventing the problems often associated with POP (postural torticollis, muscle contracture in the neck, benign scoliosis, immaturity in axial control).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participation of parents in the prenatal course at 34-38 weeks of gestation;
- •Signing of the informed consent form;
排除标准
- •parents (mother or both) aged < 18 years;
- •foreign parents with difficulty in understanding the Italian language and therefore giving informed consent to the study.
- •In addition, children who present the following conditions at birth has been excluded from the study:
- •prematurity with gestational age < 36 weeks;
- •neonatal distress;
- •congenital occipital plagiocephaly - with cranial asymmetry measurable using a craniometer and ODDI (cranial asymmetry index) > 112.6%;
- •clavicle fractures;
- •congenital clubfoot, metatarsus varus;
- •congenital spinal and pelvic abnormalities.
结局指标
主要结局
Difference in the ODDI index measured with a craniometer
时间窗: 0,3 months post born
次要结局
- Difference in number of children affected by torticollis, benign scoliosis, axial immaturity in control group and intervention group(0,3 months afther birth)
研究者
Viola Fortini
Physiotherapist
Meyer Children's Hospital IRCCS