Nonsynostotic Plagiocephaly
Conditions
Keywords
Plagiocephaly
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.
Interventions
OTHERNon-interventional
Observational
Sponsors
Boston Children's Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 8 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Qualitatively Determined Normalization of White Matter Pathways | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Improved Developmental Exams Post Helmet Therapy | 2-6 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Improved Cranial Asymmetry After Cranial Orthotic Treatment | Collected retrospectively | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm; Non-interventional A convenience sample of infants born at term gestation, \</= 6 months of age with significant Deformational Plagiocephaly (DP) (defined as head flattening requiring helmet therapy) and no major health issues will be recruited into this phase 1 descriptive pilot study
Non-interventional: Observational | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Single Arm; Non-interventional |
|---|---|
| Age, Categorical <=18 years | 2 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 6 months |
| Cranial vault asymmetry index (CVAI) > 8.75% | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
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.
Time frame: 2-6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm; Non-interventional | Number of Participants With Qualitatively Determined Normalization of White Matter Pathways | 2 Participants |
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.
Time frame: 2-6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm; Non-interventional | Number of Participants With Improved Developmental Exams Post Helmet Therapy | 2 Participants |
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.
Time frame: Collected retrospectively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm; Non-interventional | Number of Participants With Improved Cranial Asymmetry After Cranial Orthotic Treatment | 2 participants |