Abstract
Objective
This study evaluates the safety and parent satisfaction of a new cranial orthosis designed to treat deformational plagiocephaly.
Design
A retrospective phone survey of parental satisfaction of a new cranial orthosis that has Food and Drug Administration (FDA) clearance for treatment of deformational plagiocephaly.
Setting
A tertiary referral center for children with craniofacial anomalies.
Patients
The first 232 consecutive infants enrolled in this program were retrospectively reviewed.
Interventions
Infants were entered in the cranial orthosis program if they had been diagnosed with deformational plagiocephaly and were less than 1 year of age, and if the infant's parents were interested in enrolling in a monitored cranial orthosis program.
Main Outcome Measure
After completing therapy, a random sample of 81 parents (half completing treatment) was surveyed. Parents rated the improvement in their infant's head shape from 1 (least) to 5 (most). They were asked if they would repeat the program with a subsequent child. To date, 70% (162/ 232) have completed treatment.
Results
The orthosis was worn an average of 89 days. On average, parents rated head shape improvement 4.06 out of 5 (range, 3 to 5). Of parents surveyed, 81 (100%) would repeat the program with a subsequent child. There were three (3/232 or 1.3%) minor complications: one child with a persistent rash that resolved with termination of orthosis use, one child with a skin irritation that resolved with orthosis recontouring, and one child who could not be successfully fit.
Conclusions
The CranioCap, a new cranial orthosis with clearance for treatment of deformational plagiocephaly, appears to be safe, well tolerated, and has excellent parent satisfaction.
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