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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm; Non-interventional | A convenience sample of 10-15 infants born at term gestation, that are \ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional | Other | Observational |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Qualitatively Determined Normalization of White Matter Pathways | 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. | 2-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Improved Developmental Exams Post Helmet Therapy | The Mullen (Scales of Early Learning) was used to determine developmental scores. This tool provides a profile of cognitive ability in five areas: Gross Motor, Fine Motor, Expressive Language, Receptive Language, and Visual Reception. Each of the 5 assessment that has a raw score that is then given a percentile rank and descriptive category (below average, average, above average) for interpretation purposes. Descriptive categories pre treatment were compared to post treatment to determine if scores had improved. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Improved Cranial Asymmetry After Cranial Orthotic Treatment | Cranial asymmetry was assessed using the Cranial Vault Asymmetry Index (CVAI). MRI's were utilized to determine CVAI. Asymmetry pre treatment was compared to post treatment to see if asymmetry improved. | Collected retrospectively |
Inclusion Criteria:
Exclusion Criteria:
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Deformational Plagiocephaly in full term, healthy infants.
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| Name | Affiliation | Role |
|---|---|---|
| Michele DeGrazia, PhD, RN, NNP | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm; Non-interventional | A convenience sample of 10-15 infants born at term gestation, that are \ |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm; Non-interventional | A convenience sample of infants born at term gestation, \ |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Qualitatively Determined Normalization of White Matter Pathways | 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. | Posted | Count of Participants | Participants | 2-6 months |
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm; Non-interventional | A convenience sample of infants born at term gestation, that are \ |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michele DeGrazia | Boston Children's Hospital | 617-919-1222 | michele.degrazia@childrens.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 29, 2019 | Oct 20, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D049068 | Plagiocephaly, Nonsynostotic |
| D059041 | Plagiocephaly |
| ID | Term |
|---|---|
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D000013 | Congenital Abnormalities |
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| 2-6 months |
| Participants |
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| Age, Continuous | Median | Full Range | months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Cranial vault asymmetry index (CVAI) > 8.75% | Cranial vault asymmetry (CVA): the absolute difference in cranial diagonals. Cranial vault asymmetry (CVAI): measure of cranial vault asymmetry in relationship to the overall size of the head, it is the difference between the diagonals divided by the longer of the diagonals multiplied by 100. | Count of Participants | Participants |
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| Participants |
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| Secondary | Number of Participants With Improved Developmental Exams Post Helmet Therapy | The Mullen (Scales of Early Learning) was used to determine developmental scores. This tool provides a profile of cognitive ability in five areas: Gross Motor, Fine Motor, Expressive Language, Receptive Language, and Visual Reception. Each of the 5 assessment that has a raw score that is then given a percentile rank and descriptive category (below average, average, above average) for interpretation purposes. Descriptive categories pre treatment were compared to post treatment to determine if scores had improved. | Posted | Count of Participants | Participants | 2-6 months |
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| Other Pre-specified | Number of Participants With Improved Cranial Asymmetry After Cranial Orthotic Treatment | Cranial asymmetry was assessed using the Cranial Vault Asymmetry Index (CVAI). MRI's were utilized to determine CVAI. Asymmetry pre treatment was compared to post treatment to see if asymmetry improved. | Posted | Number | participants | Collected retrospectively |
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| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |