In Response to the July 2007 Issue of Parents Magazine --- “New Fix for Flat Heads”

The July 2007 issue of Parents Magazine includes a  news brief entitled “New Fix for Flat Heads”.  This news brief has many parents wondering about the claim that “an off-the-shelf (prefabricated), adjustable helmet that costs $600 is equally effective and cures babies in the same amount of time—about 5 months”, as compared to custom cranial remolding headbands that cost around $3,000, as quoted in the publication. 

In an effort to find more information about this off-the-shelf, prefabricated Danmar CAP helmet, we visited the manufacturer’s website, as referenced in the news brief.  However, while reviewing the web site, we found neither the study nor further explanation of the claims made in the news brief.  Instead, the website and news brief actually contradict each other:  The website reported that the average length of wearing time for the prefabricated helmet is 9.6 months, not 5 months, as stated in the news brief.  Most studies on custom cranial remolding orthoses indicate that treatment is completed in less than 5 months

In addition, an extensive search of medical research did not disclose any “recent” study out of Wake Forest University Baptist Medical Center.  However, an OVID search located two abstracts from presentations delivered in Queensland, Australia in 2005, along with a Reuters news story in November 2006. The interviewed author was Lisa David, a craniofacial specialist out of Wake Forest.  These abstracts presented no information to support the claim that the prefabricated helmet is “as effective as a custom cranial remolding orthoses”, as stated in the July 2007 Parents’ Magazine news brief.  

Unlike the one (or two) size(s) fits all approach of the prefabricated Danmar helmet, custom cranial remolding headbands are truly custom-made for the specific, unique head shape of each baby in need of treatment.  While custom cranial headbands are more expensive than the prefabricated helmet, the price of a custom cranial remolding headband includes frequent follow-up appointments that allow the practitioner to closely monitor the baby’s progress, make adjustments to the headband to account for the baby’s rapid growth, and to maximize treatment results.

Abstract clinical data clearly shows that the $600 prefabricated Danmar helmet  does not approach the effectiveness of custom cranial remolding orthoses.  The abstract indicates that the prefab band improved the asymmetry only 27%, which does not compare favorably to a peer reviewed research by Graham which indicated a 61% improvement in asymmetry with custom cranial remolding orthosis1.  This 27% percentage for improvement with the prefabricated helmet is even lower than the improvement rate published in the same (Graham) study for repositioning1.  It is difficult to determine how the authors of the Wake Forest study can conclude that the prefabricated helmet is “just as effective as a custom orthosis” when it isn’t even as effective as basic positioning efforts that are free and can also promote higher level developmental skills. In addition, these abstracts never discussed using repositioning as a first strategy toward reducing head shape deformities, a widely accepted recommendation that has been mentioned in most articles ever published by craniofacial experts on the subject. It is important for parents to know that the prefabricated helmet simply provides positioning assistance, unlike custom cranial remolding headbands that actively reshape the baby’s head.  In addition, parents need to understand that their own efforts to incorporate positioning techniques, such as tummy time, into the baby’s daily routine are likely to be even more effective than the improvement reported in the abstract about the Danmar helmet. 

The writers of the abstract concluded that the patients “most likely to benefit from this type of helmet therapy are those that have moderate to severe deformities and wear the helmets >12 hours/day”.  The article never provided any treatment ranges that would allow others to determine the severity level of the babies treated.  The prefabricated helmet only comes in only two sizes, despite the multitude of head shape sizes and shape deformities present in babies with deformational plagiocephaly.

Custom cranial remolding orthoses represent the gold standard of care for babies with moderate to severe head shape deformities.  This statement is based on published clinical studies proving their clinical effectiveness, safety and superior patient outcomes.  Orthomerica’s own experience with custom remolding orthoses is witness to the success of custom STARband treatment for over 50,000 babies worldwide.

Analysis of the prefabricated Danmar helmet reveals significant concerns with the design. These concerns include, but are not limited to the following:

1. The top/back trim line does not hold over the baby’s high cranial vault—a feature present in most babies with severe head shape deformities and many with moderate deformities.
2. The plastic over the forehead does not extend down far enough to correct frontal deformities.  The abstract from Wake Forest acknowledges that there was no change in temporal bossing in brachycephaly with the prefabricated helmet.
3. Unlike custom cranial headbands, the orthotist cannot remove foam from the inside of the prefabricated helmet to precisely direct growth.  Rather, space is allowed inside the helmet that may or may not correspond to the baby’s unique head shape.
4. The prefabricated helmet is a generic circle of plastic with a positioning block attached.  As such, it should be seen as more of a positioning device than a cranial remolding headband.  Based on the results in the abstract (27% improvement), however, the expensive $600 price tag for simply a positioning device may not warrant its use--even for that purpose.  Parents are likely to get better results with their own repositioning efforts (free of charge!) that can also promote the development of higher level motor skills in addition to promoting better symmetry of their baby’s head.
5. Practitioners who have fit the CAP helmet feel that the fact that only two sizes are available to manage babies with thousands of different head shape deformities makes the device a difficult and poor fit.  Few practitioners are willing to fit a device that has poor results yet takes considerable time to fit.
6. The prefabricated Danmar orthosis reduces pressure only over flattened areas without any attention to areas of bossing.  STAR custom cranial remolding headbands hold over the areas of bossing (without pressure) to prevent undesirable growth and redirect growth into areas that will promote symmetry and proportion.  Each STARband is precisely made to correct the asymmetry and proportion of each baby’s unique head shape.

Treatment for head shape problems is limited to the time the baby’s head is rapidly growing—especially during the first year of life.  So we are disappointed that Parents’ Magazine did not collect and offer all the facts about effectively treating deformational plagiocephaly and other head shape problems.  We are hopeful that this letter and the letter written to the editor of Parents Magazine will reassure parents that their own positioning efforts can be very successful, and when necessary, custom cranial remolding orthoses, like the STARband, present the best opportunity for optimal improvement in their baby’s head shape.

If practitioners or parents would like more information about ways to incorporate positioning and handling techniques into their baby’s day in order to help prevent or improve head shapes of babies with deformational plagiocephaly, they can download free Tummy Time information at www.orthomerica.com.

Orthomerica has sent a letter to the editor at Parents Magazine, and hopes that the magazine will be interested in investigating this further.  Orthomerica has offered to supply the magazine with published research and clinical information supporting these aforementioned concerns.

1.  Graham JM, Gomez M, Halberg A, Earl DL, Kreutzman JT, Cui J, Guo X.
     Management of Deformational Plagiocephaly:  Repositioning Versus  Orthotic
     Therapy. J Pediatr 2005; 146:258-262.

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For more information about Orthomerica's STARband Cranial Remolding Orthosis, call us at 877.737.8444 or email custserv@orthomerica.com

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