N/A
N=10
Brain Characteristics Noted Prior to and Following Treatment
Nonsynostotic Plagiocephaly
Bottom Line
View on ClinicalTrials.gov: NCT02392195 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Number of Participants With Qualitatively Determined Normalization of White Matter Pathways — 2 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Non-interventional (Other)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Boston Children's Hospital
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Qualitatively Determined Normalization of White Matter Pathways |
2 | — |
| SECONDARY Number of Participants With Improved Developmental Exams Post Helmet Therapy |
2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- - DP requiring helmet therapy
- -Term gestation at birth (37 weeks or greater)
- -Less than/or equal to 8 months of age
- -No history of major health problem such as birth injury, genetic disorder, intracranial hemorrhage, hydrocephalus, neurologic abnormality
- -No history of implantable metal device or internal/external orthotic device
Exclusion Criteria
- - DP not requiring helmet therapy
- -Premature gestation at birth (less than 37 weeks gestation).
- -Greater than 8 months of age
- -History of major health problem such as birth injury genetic disorder, intracranial hemorrhage, hydrocephalus, neurologic abnormality
- -History of implantable metal device or internal/external orthotic device
- -Infants not completing prescribed treatment for correction with a helmet
Data sourced from ClinicalTrials.gov (NCT02392195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.