Research Study to Look at P.A.P. Cranial Helmet

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By Miki Fairley

The P.A.P. (Plagiocephalic Applied Pressure) Cranial Remolding Orthosis developed by Fit-Well Prosthetic & Orthotic Center, Salt Lake City, Utah, will be the focus of a study later this year in collaboration with Primary Children's Medical Center, Salt Lake City. The study will look at the effectiveness of cranial remolding helmets in treating positional plagiocephaly.

This is not the first study involving the P.A.P. orthosis. The company supplied results to the US Food and Drug Administration (FDA) from 195 infant cases showing that the orthosis is safe and effective. FDA clearance was granted in January 2002.

The planned study will use a new 3-D scanning system from Polhemus, Colchester, Vermont, a noted developer of sixDegree-of-Freedom (6DOF) motion tracking, digitizing, eye-tracking, and handheld 3D scanners.

Triplets Participate

An unusual trio of subjects will be among those involved in the study: Jack and Nicole Skadal's infant triplets. All three are being fitted with the P.A.P. helmets. They will be wearing the helmets 23 hours per day for three months. The P.A.P. orthosis, the planned study, and the Skadal triplets were featured on KSL TV, Salt Lake City, earlier this year. The triplets were born seven weeks premature, so had seven additional weeks in the hospital on their backs, flat on their heads, Nicole Skadal pointed out in the television interview.

Plagiocephaly Cases Rise

Plagiocephaly is a condition characterized by a parallelogram head shape and a persistent flattened spot on the back or one side of the head.Positional or deformational plagiocephaly is most commonly caused by the position in which the baby spends the most of his or her time. The American Academy of Pediatrics (AAP) recommendation that all newborns and infants sleep on their back has probably led to the rise in cases in recent years, according to www.keepkidshealthy.com . On a positive note, The Back to Sleep campaign sponsored by the National Institute of Child Health and Human Development (NICHD), the AAP, and the SIDS Alliance, among others, has led to a large decrease in the number of children who die from Sudden Infant Death Syndrome (SIDS), the website added.

Mild deformities usually will correct on their own with these measures, the website notes, adding, "If there is no improvement in a few months, then children with positional plagiocephaly may need treatment with a molding helmet or head band."

Some children with congenital torticollis, as well as premature infants, are prone to get a flat head, the website explains. "if treatment [of positional plagiocephaly] is begun early, usually before six months of age, the results will be very good, with a normal or near-normal head shape." The website notes that, in cases of positional plagiocephaly, the brain continues to grow normally.

Craniosynostosis is a much graver condition, the premature fusion of the cranial sutures. Craniosynostosis can occur as an isolated defect or as part of a syndrome, explains Majid A Khan, MD, in an online article at www.emedicine.com . The condition usually requires surgery. Sometimes cranial helmets also are used beneficially after surgeries, said Chris Hunsaker of Fit-Well.

Transparency Helps

The P.A.P. orthosis utilizes DuPont® Surlyn®. Since it is transparent, it allows the skin to be seen for easy inspection by parents or caregivers. This visual inspection helps prevent skin breakdown, irritation, and possible sores, the company notes. It is more flexible than traditional plastics used, which aids in suspending the device on the infant's head; it is less bulky; and it allows for growth modifications as the infant's head develops, according to Fit-Well. The company is seeking patent protection for its methods used to create the P.A.P. orthosis.

Fit-Well also plans to use 3-D scans to make more precision fits for other prosthetic and orthotic applications, the company said. Fit-Well Prosthetic and Orthotic Center has been in business since 1908.

For more information about Fit-Well, visit www.fit-well.com
Formore information about Primary Children's Medical Center, visit http://intermountainhealthcare.org/xp/public/primary/
For more information about Polhemus scanning devices, visit www.polhemus.com