Research Shows Helmet Therapy For Children With Skull flatness Shows Little Or No Effectiveness

Roughly one baby in five under the age of 6 months develops a skull deformation caused by lying in a supine position. Now a study has found that a common remedy for the problem, an expensive custom-made helmet worn by infants, in most cases produces no more improvement in skull shape than doing nothing at all.

The new report, published Thursday in the journal BMJ, is the first randomized trial of the helmets. The authors found “virtually no treatment effect,” said Brent R. Collett, an investigator at Seattle Children’s Research Institute and author of an accompanying editorial.

Skull flatness at back of the head may be accompanied by facial asymmetry; one ear may be slightly farther back than the other, and sometimes the side of the head can flatten. Until now, less rigorous studies had mostly shown helmets did help normalize head shape.

The helmets are sometimes adorned with stickers, and are sometimes painted to resemble a pilot’s helmet or with the logo of a beloved football team. “I was very surprised at the results,” Dr. Mark R. Proctor, an associate professor of neurosurgery at Boston Children’s Hospital, said of the new study, adding that it was “rigorous.”

Still, the study leaves open the possibility that the helmets may still be useful for infants with severe skull flattening and those with tight neck muscles, which make it hard for infants to turn their heads, so they remain in one position. 

Renske M. van Wijk and researchers at the University of Twente in the Netherlands assigned 42 babies who had misshapen skulls, aged 5 to 6 months old, to wear a custom-designed helmet that allows flattened areas room to round out as the infant’s skull expands.

Parents were instructed to have infants wear the helmets 23 hours a day for six months or so. Another 42 babies with similar deformities received no treatment. Infants with the most severe deformities were excluded.

After two years, a researcher who did not know which babies had worn helmets evaluated skull shape in the infants. The improvements were not significantly different between the helmet-wearers and the infants not wearing helmets.

“There are definitely cases of infants with mild to moderate skull deformation who are treated with helmet therapy, and this study confirms and reaffirms that this is not necessary,” said Dr. James J. Laughlin, an author of the policy statement on skull deformities for the American Academy of Pediatrics.

Helmets to treat flattened skulls range in price from $1,300 to $3,000, and parents are told to make sure infants wear them around the clock. Dr. Laughlin said the paper provides pediatricians and worried parents “reassurance that not doing helmet therapy will give you the same results as doing helmet therapy, which is expensive” and can be “stressful for the family.”

Makers of custom helmets questioned the study’s results. Tim Littlefield, a spokesman for Cranial Technologies, called it “inherently flawed.” William Gustavson, a spokesman for Orthomerica, called it “alarming” that nearly three-quarters of parents whose children received helmets in the study reported that the helmets shifted or rotated on their infants’ heads.

“The value of this research is fully reliant upon the quality of the fit,” said James Campbell, the vice president of the American Orthotic and Prosthetic Association, a trade group.

well.blogs.nytimes