An observational study in Nonsynostotic Plagiocephaly, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged Up to 8 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-10.
Sponsored by Boston Children's Hospital · Observational
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.
16 studies on the registry are indexed under Plagiocephaly; 4 are open to participants now.
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Deformational Plagiocephaly in full term, healthy infants.
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Exclusion Criteria:
A convenience sample of 10-15 infants born at term gestation, that are \</= 6 months of age with significant DP (defined as head flattening requiring helmet therapy) and no major health issues will be recruited into this phase 1 descriptive pilot study
Other: Non-interventional
Observational
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
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
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
| Milestone | Single Arm; Non-interventional |
|---|---|
| Started | 10 |
| Completed | 2 |
| Not completed | 8 |
| Withdrew: Lost to follow-up | 4 |
| Withdrew: Withdrawal by subject | 4 |
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.
| Participants | Single Arm; Non-interventional |
|---|---|
| Number of Participants With Qualitatively Determined Normalization of White Matter Pathways | 2 |
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.
| Participants | Single Arm; Non-interventional |
|---|---|
| Number of Participants With Improved Developmental Exams Post Helmet Therapy | 2 |
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.
| participants | Single Arm; Non-interventional |
|---|---|
| Number of Participants With Improved Cranial Asymmetry After Cranial Orthotic Treatment | 2 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Arm; Non-interventional | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Single Arm; Non-interventional |
|---|---|
| <=18 years | 2 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(months) | Single Arm; Non-interventional |
|---|---|
| Median | 6 (5 to 7) |
| Sex: Female, Male(Participants) | Single Arm; Non-interventional |
|---|---|
| Female | 2 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Single Arm; Non-interventional |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 1 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Single Arm; Non-interventional |
|---|---|
| United States | 2 |
| Cranial vault asymmetry index (CVAI) > 8.75%(Participants) | Single Arm; Non-interventional |
|---|---|
| Count of participants | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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