Interest of an Early Osteopathic Treatment in Infants in the Prevention of Cranial Deformations : Positional Plagiocephaly and Brachycephaly.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Positionnal skull deformation : plagiocephaly and brachycephaly
研究概览
简要总结
Positional cranial deformities (PCD), plagiocephaly and brachycephaly are a common reason for pediatric consultation, which has increased significantly since the recommendation to lay babies on their backs to prevent unexpected infant death (ILD). CPD is a source of concern for parents about their impact on psychomotor development and the aesthetic risk of deformity. The High Authority for Health (HAS) will soon put in place recommendations with a fact sheet for health professionals and the public. The aim of this research is to study whether early treatment of rotation disorders and hypertonia in newborns by manual osteopathic techniques would prevent the occurrence of positional deformities of the skull.
The main objective is to evaluate the effectiveness of an early osteopathic treatment on the rate of CPP (plagiocephalic and postural brachycephalia) at 4 months in newborns at risk.
the secondary objective is: to evaluate the effectiveness of an early osteopathic treatment on the quality of life of the child at 4 months.
Methodology: Controlled, randomized monocentric two-arm parallel study between (1) osteopathic follow-up and (2) osteopathy-free follow-up. The inclusion period will be 18 months and the follow-up period is 4 months.
Procedure: The two groups will be evaluated at 3 days and 4 months. The experimental group will benefit from an osteopathic treatment of 3 days of life to 4 months with a frequency of 3 to 4 sessions. Both groups will benefit from sleeping, carrying, positioning and stimulation advice.
The perspectives are:
- the decrease in the prevalence of CPP after early osteopathic treatment.
- Defining a decision algorithm for early osteopathic treatment.
- Subject to recommendations on the indication of early osteopathic treatment in neonates at risk.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Days 至 11 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn baby aged 3 days and until the maternity leave
- •Newborn with at least one risk factor for cranial deformity:
- •Newborn who received instrumental vaginal delivery.
- •Newborn presenting:
- •a preferential side,
- •global axial hypertonia,
- •Localized suboccipital hypertonia
- •Newborn presenting:
- •cranial deformity at birth,
- •a deformation of the face,
- •deformity of the trunk in scoliosis, comma or hyperextension
排除标准
- •Newborn with congenital muscular torticollis (managed directly in physiotherapy)
- •Premature neonate (<37SA)
- •Newborn with a malformation pathology
- •Newborn with craniosynostosis.
- •Newborn with a contraindication to the practice of osteopathy.
结局指标
主要结局
Positionnal skull deformation : plagiocephaly and brachycephaly
时间窗: four month
cranial vault asymetry index and cranial index measured with caliper between the age of 3 to 10 days and at 4 months measured blind of the randomization arm
次要结局
- Questionnaire QUALIN(fourth month)