Expired Study
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Boston, Massachusetts 02115


Purpose:

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.


Study 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.


Criteria:

Inclusion Criteria: 1. - DP requiring helmet therapy 2. -Term gestation at birth (37 weeks or greater) 3. -Less than/or equal to 8 months of age 4. -No history of major health problem such as birth injury, genetic disorder, intracranial hemorrhage, hydrocephalus, neurologic abnormality 5. -No history of implantable metal device or internal/external orthotic device Exclusion Criteria: 1. - DP not requiring helmet therapy 2. -Premature gestation at birth (less than 37 weeks gestation). 3. -Greater than 8 months of age 4. -History of major health problem such as birth injury genetic disorder, intracranial hemorrhage, hydrocephalus, neurologic abnormality 5. -History of implantable metal device or internal/external orthotic device 6. -Infants not completing prescribed treatment for correction with a helmet


NCT ID:

NCT02392195


Primary Contact:

Principal Investigator
Michele DeGrazia, PhD, RN, NNP
Boston Children’s Hospital


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02115
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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