Clinical trial NCT02392195: Brain Characteristics Noted Prior to and Following Treatment
Official title: Brain Characteristics Noted Prior to and Following Treatment of Deformational Plagiocephaly With a Helmet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nonsynostotic Plagiocephaly
Keywords: Plagiocephaly
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2015-03-18
Enrollment: 10
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Deformational Plagiocephaly in full term, healthy infants.

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 description: 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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Qualitatively Determined Normalization of White Matter Pathways
timeFrame: 2-6 months
Secondary outcomes:
measure: Number of Participants With Improved Developmental Exams Post Helmet Therapy
timeFrame: 2-6 months
Other outcomes:
measure: Number of Participants With Improved Cranial Asymmetry After Cranial Orthotic Treatment
timeFrame: Collected retrospectively
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Michele DeGrazia, PhD, RN, NNP
role: PRINCIPAL_INVESTIGATOR
References: