Description of Treatment/Procedure:

Deformational plagiocephaly refers to cranial asymmetries without synostosis. The infant is typically born without a flattened region of the skull but develops one within a few weeks or months. Viewed from above, the head has a parallelogram shape. Deformational plagiocephaly is purely an aesthetic issue; brain function is not affected. An increase in cases of deformational plagiocephaly has been attributed to the American Academy of Pediatrics' 1992 recommendation that infants be placed to sleep on their backs to reduce the risk of sudden infant death syndrome. Treatments include repositioning of the infant's head to avoid constant pressure on one spot, stretching exercises (if torticollis is present), cranial orthoses, and surgery. The focus of this report is on cranial orthoses. These devices are designed to inhibit growth in some areas and enable growth in others to improve cranial asymmetry and/or shape. Cranial orthoses are regulated by the United States Food and Drug Administration as Class II neurology devices.

Committee Summary

With regard to cranial orthoses for deformational plagiocephaly, the ICSI Technology Assessment Committee finds:

1. Deformational plagiocephaly is largely preventable by alternating right and left head positioning when sleeping, minimizing prolonged periods in seating devices that maintain a supine position, and appropriately using prone positioning during awake time. Prevention is most likely to be effective in children under 6 months of age.
   
2. Cranial orthoses should only be used for infants with moderate to severe deformational plagiocephaly after failure of a 6 to 8 week trial of repositioning therapy. At present, there is no objective definition of moderate to severe plagiocephaly.
   
3. Cranial orthoses are safe when prescribed by experienced, qualified individuals and used as directed.
   
4. In case series and non-randomized trials, cranial orthoses have been found to be effective in reducing cranial asymmetries. Although the evidence is limited, the balance of the literature supports the use of cranial orthoses before 12 months of age. There is evidence that positional therapy, a more conservative treatment, is only effective when employed early (i.e., at 2 to 4 months of age). Randomized, controlled trials with objective outcome measures are needed to clarify the potential benefits of positional therapy and cranial orthoses. (Conclusion Grade II)