Parental satisfaction with the CranioCap: a new cranial orthosis for deformational plagiocephaly.

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.