Newborn Head Molding and Later Asymmetries in Follow up (3D Head Shape Modelling)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Presence of Plagiocephaly (The number of children in groups with plagiocephaly (CI, OCLR =/> 104% )
研究概览
简要总结
Prospective randomized clinical interventional trial after birth in maternity ward, and follow up to 8-9 years of age.
Hypothesis: Preventive handling and caring advices to parents of newborns decrease craniofacial asymmetries (deformational plagiocephaly and torticollis). The minimum sample size of the study was calculated at 86 (43 in each arm) using a 5% significance level, a power of 80% and a fall in the prevalence of DP from 31% to 8%. Craniofacial asymmetries and appearances of occlusal defects are followed up to 9 years. 50 preterm infants can participate without intervention.
详细描述
The amount of craniofacial abnormal molding after birth in newborns and the frequency of plagiocephaly in infancy or later consequences of those in childhood are not known in finnish population. Head malposition and deformational plagiocephaly, however, have been linked to delayed development in early life and even much later to orthognathic problems demanding surgery in adulthood.
In this study parents with healthy newborns are randomized to have normal discharge home or discharged with extra advice information for caregivers; to charge both sided feeding and handling habits; to change regularly sleeping and lying positions; to have early tummy times.
Anthropometric measurements of the infants; tilting degrees of the head and rotations of the neck (range of movement =ROM) are taken at discharge home and at the age of 3 and 6 months, and 1, 3, 5-6 and 8-9 years. Two-dimensional digital photographs (upto the age of 6 months) and three-dimensional imaging (from the age of 3 months) are taken to measurements of the head shape (Cephalic index=CI and (approximate) Oblique Cranial Length Ratio= (a)OCLR measured using a semiautomated, computer-based method). The development quotient by Griffiths scales are assessed at the age of 3 and 6 months. Dental occlusal defect evaluation are started at the age of 3 ys.
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
- Single (Investigator)
入排标准
- 年龄范围
- 1 Day 至 6 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1-6 days after birth;
- •Healthy newborns in maternal ward, and living in near by Oulu region.
- •Preterms at the age of 34-44 gestation weeks in near by Oulu region (non randomized)
排除标准
- •Congenital anomalies,
- •Very early discharge,
- •Parental refusal
结局指标
主要结局
Presence of Plagiocephaly (The number of children in groups with plagiocephaly (CI, OCLR =/> 104% )
时间窗: 3 months
The number of children in groups with plagiocephaly (CI, OCLR =/\> 104%)
次要结局
- Severity of plagiocephaly(3 months)
- Change in occlusal defects(from 10 years to 15 years)
- Change in facial symmetry(from 10 years to 15 years)
- Change in plagiocephaly(From 3 to 6 months)
- Occlusal defects(6 years)
研究者
Marita Valkama
PhD, M.D. Adjunct Professor, pediatrician and neonatologist
University of Oulu