Clinical Trial: Brain Characteristics Noted Prior to and Following Treatment

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Boston Children’s Hospital

Current Primary Outcome:

  • Brain volume [ Time Frame: 2-6 months ]
    We will compare if brain volume appreciably changes in the area of head flattening following helmet therapy
  • Nerve pathways [ Time Frame: 2-6 months ]
    We will compare if nerve pathways are appreciably different in the area of head flattening following helmet therapy
  • Blood flow [ Time Frame: 2-6 months ]
    We will compare if blood flow is appreciably different in following helmet therapy in the area of head flattening
  • Brain oxygen use [ Time Frame: 2-6 months ]
    We will compare if brain oxygen use is appreciably different in following helmet therapy in the area of head flattening


Original Primary Outcome: Same as current

Current Secondary Outcome: Developmental examination [ Time Frame: 2-6 months ]

We will compare developmental exam scores pre and post helmet therapy


Original Secondary Outcome: Same as current

Information By: Boston Children’s Hospital

Dates:
Date Received: March 12, 2015
Date Started: February 2013
Date Completion:
Last Updated: May 2, 2017
Last Verified: May 2017