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•General Pediatrics
Helmets a Bad ‘Fit’ for Flat Head Syndrome
Helmet therapy for flat head syndrome in infants did not improve skull shape by 2 years of age, researchers reported.

The randomized controlled clinical trial tested the use of helmet therapy in 84 infants (average age 6 months) and found that about one in four of the babies fitted with helmets had improvements, which was roughly the same improvement seen in the control group, (odds ratio 1.2, 95% CI 0.4-3.3, P=0.74), according to Renske M. van Wijk, a PhD candidate at the University of Twente in the Netherlands, and colleagues.

Every baby in the helmet group wore the helmets for 4 to 6 months and each of them experienced side-effects, which, coupled with a treatment costs estimated at $1,935 per child, led van Wijk and colleagues to find no justification for the treatment. They published their findings May 1 in BMJ.

“Positional plagiocephaly [flattening of the head on one side] and brachycephaly [flattening of the back of the head, which creates a cone shape at the top of the skull] affects approximately 20% of infants and is the most common reason for referral in many craniofacial centers,” Brett R. Collett, PhD, a craniofacial, behavioral, and mental health specialist at Seattle Children’s Research Institute, wrote in an editorial in BMJ.

Collett suggests that skull deformations in one out of five infants are directly related to campaigns in several countries which recommend supine positioning for sleeping infants in an effort to reduce sudden infant death syndrome (SIDS). In the U.S., Safe to Sleep started back in the early ’90s.

But Collett notes that an increase in advertising for orthotic treatments, like expensive, awkward baby helmets, boosted public awareness of misshapen skulls and the awareness of a therapy as well.

“It is worth highlighting that in neither group in this study did head shape ‘normalize’ by the end of the trial,” Collett wrote in the editorial.

The Research

For the HElmet therapy Assessment in Deformed Skulls (HEADS) trial, 84 infants, ages 5 to 6 months, with moderate to severe skull deformation were randomized at four locations to either receive helmet therapy or no therapeutic intervention for 6 months. None of the infants had muscular torticollis, craniosynostosis, or dysmorphic features.

On average, the babies in the helmet group stopped wearing the device at 10 months of age.

Final measurements were taken when the infants reached 24 months of age for the primary outcome. And secondary outcome measures were collected in ear deviation, facial asymmetry, occipital lift, motor development, parental satisfaction, and infant and parental quality of life.

Changes in plagiocephaly scores between the two groups were equal (mean difference -0.2, 95% CI minus 1.6-1.2, P=0.80). Changes in brachycephaly scores were also equal between the two groups (mean difference 0.2, 95% minus 1.7-2.2, P=0.81).

The stamp of “Full recovery” was given to 10 out of 39 children in the helmet therapy group (26%), and nine out of 40 in the no intervention group (23%) (OR 1.2, 95% CI 0.4-3.3, P=0.74). Five of the participants did not return for the final measurements.

In the helmet therapy group, every single parent reported at least one side effect from the device.

Although fewer sleep problems and fewer hours crying were reported in the helmet therapy group compared with the no therapy group (14% versus 24%, and 1.4 hours versus 1.2 hours), 96% of parents reported skin irritation, 24% reported that their child resisted wearing the helmet, 71% said the helmet caused sweating, 76% said the helmet generated an unpleasant smell, 33% said the helmet caused pain, and 77% of the parents said they felt hindered when cuddling their child.

None of the secondary outcomes were significant between groups.

Van Wijk and colleagues wrote that in both arms of the study, brachycephaly showed a more favorable course of recovery than plagiocephaly. And that the outcomes of this study would be expected to hold for all types of custom-made helmets comprised of a rigid plastic shell with a foam lining designed to fit snugly.

A Pediatrician’s Perspective

“Helmets remain fairly controversial, since they are so expensive and usually not covered by insurance,” Ari Brown, MD, a pediatrician at 411 Pediatrics in Austin, Texas, told MedPage Today in an email.

“It is nice to finally have a randomized trial rather than just anecdotal experience to provide for families when they ask me if it is worth the cost to do it,” Brown said.

Brown also said that one study can’t “prove” anything. However, she said, this clinical trial is a useful beginning to explore whether or not to treat plagiocephaly and brachycephaly with helmet therapy in an objective way.

“For children who have mild to moderate plagiocephaly, no one can really tell the difference between kids who wore helmets versus those who didn’t when they are,” Brown said. “So, when given the option of an expensive intervention (and the downside of cuddling less with your baby) versus trying to keep the little one off of the back of their heads during wakeful hours, it’s hard to justify the cost of the intervention.”

“The Back to Sleep Campaign began in 1992, and we have seen an enormous increase in plagiocephaly since that time,” Brown echoed Collett.

“However, there are also many more infant reclining gadgets that have hit the market — allowing babies to hang out without a parent holding them — during wakeful hours. That combination of reclining while awake and sleeping on the back has led to this huge increase in flat-headed babies,” Brown said.

“It’s important to keep babies off the back of their heads when they are awake, since sleeping on their backs is such a critical way to help prevent SIDS.”

“There is no question that the head shape improves more quickly when a baby wears a helmet — but if you were to ask me which kid wore a helmet at age 2 and which kid didn’t, like the study, I probably would not know,” Brown said. “So the outcome is about the same; it just occurs more quickly with a child in a helmet.”

Brown said she sees an area for future research, “I would like to see the study done on children with severe plagiocephaly. That is where helmets may make the most difference.”

Collett also mentioned this. “Future studies, including larger samples, would be helpful in determining whether some infants respond more favorably than others. In particular, it would be of interest to learn whether children with the most severe positional plagiocephaly and brachycephaly, who were excluded from this trial, show meaningful improvement.”

Collett wrote that the very low rate of participation (21%) in the trial would also be a problem for future studies. “Parents interested in their child receiving orthotic treatment for positional plagiocephaly and brachycephaly are understandably reluctant to have that decision randomized.”

“[A]dditional work incorporating behavioral and public health strategies to promote ‘tummy time’ and similar positioning strategies should be explored,” Collett wrote.

Funding was supported by ZonMw, the Netherlands Organization for Health Research and development. The authors declared no relevant conflicts of interest.

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