跳至主要内容
临床试验/NCT02392195
NCT02392195已完成不适用

Brain Characteristics Noted Prior to and Following Treatment of Deformational Plagiocephaly With a Helmet

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Number of Participants With Qualitatively Determined Normalization of White Matter Pathways

研究概览

简要总结

This study will enable investigators to find out if brain structure and characteristics are affected by the shape of the infant's head, and if changes in the brain occur with helmet therapy.

详细描述

A dramatic increase in the number of infants diagnosed with Deformational Plagiocephaly (DP) has been observed worldwide since institution of the American Academy of Pediatrics' Back to Sleep Program. According to one published report, the incidence of DP ranges between 3-48%; this translates into120,000-2 million infants/year who develop DP in the United States alone. Some healthcare providers believe that DP is a purely cosmetic condition. This mindset undermines the importance of prevention and correction. In New Zealand, a recent study demonstrated that 39% of children without corrective action had persistent DP at age 3 to 4 years. Additionally, several studies have demonstrated associations between impaired social interactions, developmental problems and DP.Thus some researchers now believe that there may be a spectrum of untoward outcomes from brain remodeling resulting from DP. Recent technological advances now allow the detection of diminutive changes in brain structure. In this multidisciplinary descriptive pilot study we will use brain MRI (Magnetic Resonance Imaging) and a cerebral tissue oxygenation monitor, namely Frequency Domain Near Infrared and Diffuse Correlation Spectroscopy (FDNIR/DCS) to describe if differences in brain structure and characteristics exist in infants with significant DP before and after correction of the deformational defect. This study will enable investigators to seek preliminary evidence that brain development is influenced by the shape of the cranial vault, and that changes in brain structure and characteristics occur with helmet therapy. Additionally this study will help to determine the need for a larger investigation of this phenomenon that would further establish an association between DP and developmental delay.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
— 至 8 Months(Child)
性别
All
接受健康志愿者

入选标准

  • DP requiring helmet therapy
  • Term gestation at birth (37 weeks or greater)
  • Less than/or equal to 8 months of age
  • No history of major health problem such as birth injury, genetic disorder, intracranial hemorrhage, hydrocephalus, neurologic abnormality
  • No history of implantable metal device or internal/external orthotic device

排除标准

  • DP not requiring helmet therapy
  • Premature gestation at birth (less than 37 weeks gestation).
  • Greater than 8 months of age
  • History of major health problem such as birth injury genetic disorder, intracranial hemorrhage, hydrocephalus, neurologic abnormality
  • History of implantable metal device or internal/external orthotic device
  • Infants not completing prescribed treatment for correction with a helmet

结局指标

主要结局

Number of Participants With Qualitatively Determined Normalization of White Matter Pathways

时间窗: 2-6 months

We will compare if nerve pathways are appreciably different in the area of head flattening following helmet therapy by visual examination and comparison of areas of asymmetry vs. symmetry.

次要结局

  • Number of Participants With Improved Developmental Exams Post Helmet Therapy(2-6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michele DeGrazia

Director Nursing Research NICU

Boston Children's Hospital

研究点 (1)

Loading locations...

相似试验