|BMJ Helmet study — Our response.|
On May 1, 2014, the NY Times published an article discussing the recent British Medical Journal study that hypothesized that cranial helmets for babies don’t work to improve flat head syndrome. Medical professionals are now challenging the BMJ study to show that the process of the study and the equipment used to treat Plagiocephaly were incorrectly fit to the children.
|Below, find the difference of a DOC band (left) and the study helmet (right). National Association for Plagiocephaly September 3, 2014|
|☞ Helmet study highlighted in The New York Times is flawed August 4, 2014|
By Catherine Saint Louis, The New York Times May 1, 2014
Pediatricians have long urged parents to put newborns to sleep on their backs to help prevent sudden infant death syndrome. While the practice undoubtedly has saved lives, it also has increased the numbers of babies with flattened skulls.
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, AAP.
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.
Some surgeons worried that the finding would be applied too broadly, jeopardizing insurance coverage for severely affected children who could benefit from helmets.
“What I fear happening is that children with a severe deformity are going to be denied helmets based on this evidence, which is really only talking about moderate cases,” said Dr. Alex A. Kane, the director of pediatric and craniofacial surgery at UT Southwestern and Children’s Medical Center in Dallas.
Courtney Reissig, 31, a stay-at-home mother in Little Rock, Ark., doesn’t regret the eight months her son, Luke, wore a helmet. He had neck muscles so tight that he favored lying on his left side in bed, to the point that it “looked like the side of a toaster — flat, not round,” Mrs. Reissig said.
He outgrew his first helmet, which cost $1,300, and required a second, she said. But wearing a helmet helped round out his head, and he now closely resembles his twin, Zach. “I do feel like the helmets were worth it,” she said.
Only about a quarter of the babies in the BMJ trial made a full recovery by the age 2.
“This is a problem we created,” said Dr. Proctor, of Boston Children’s Hospital. “All parents are told is sleep the child on their back. They aren’t told about flat heads and how to prevent it.”
Some pediatricians and specialists advise parents to try repositioning an infant’s head before considering a helmet.
Repositioning entails alternating to which side the infant’s head turns once they are asleep on the back. That way, pressure isn’t always squarely on the back of the head.
Repositioning isn’t as feasible for infants with tight neck muscles, known as torticollis. They may benefit from physical therapy, said Dr. Chad A. Perlyn, craniofacial and pediatric plastic surgeon at Miami Children’s Hospital.
In addition to repositioning, he advises parents to try more tummy time and to limit time spent in car seats. Use a baby carrier, he added, because “when the baby is awake, there’s no deforming force on the skull.”
Doctors noted that some helmet makers encourage parents to diagnose flattened skulls on their own, without a doctor’s evaluation. It’s important for a physician to rule out craniosynostosis, or bones fusing together prematurely, as a cause, they said. That much rarer condition requires surgery.
On the Web sites of some helmet manufacturers, assessment tools encourage parents to compare their infant’s head shape to pictures.
“It’s a bit like having the wolf guarding the henhouse,” said Dr. Proctor.
Source The New York Times
Helmet therapy in infants with positional skull deformation: randomised controlled trial, van Wijk, Renske M and van Vlimmeren, Leo A and Groothuis-Oudshoorn, Catharina G M and Van der Ploeg, Catharina P B and IJzerman, Maarten J and Boere-Boonekamp, Magda M. BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g2741 (Published 01 May 2014) Full text
Helmet therapy for positional plagiocephaly and brachycephaly, Collett Brent R. BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g2906 (Published 01 May 2014)
Head shape at age 36 months among children with and without a history of positional skull deformation, Brent R. Collett, Brian G. Leroux, Erin R. Wallace, Emily Gallagher, Jason Shao, and Matthew L. Speltz. Journal of Neurosurgery: Pediatrics, Mar 2018 Vol. 21 / No. 3. Pages 204-213
Prevention and management of positional skull deformities in infants, Laughlin J, Luerssen TG, Dias MS; Committee on Practice and Ambulatory Medicine, Section on Neurological Surgery. [published correction appears in Pediatrics. 2012 Mar;129(3):595]. Pediatrics. 2011;128(6):1236-1241. doi:10.1542/peds.2011-2220
Infant Cranial Deformity: Cranial Helmet Therapy or Physiotherapy? González-Santos J, González-Bernal JJ, De-la-Fuente Anuncibay R, Soto-Cámara R, Cubo E, Aguilar-Parra JM, Trigueros R, López-Liria R. Int J Environ Res Public Health. 2020 Apr 10;17(7):2612. doi: 10.3390/ijerph17072612. Full text
Outcome Analysis of the Effects of Helmet Therapy in Infants with Brachycephaly, Choi H, Lim SH, Kim JS, Hong BY. J Clin Med. 2020 Apr 19;9(4):1171. doi: 10.3390/jcm9041171. Full text
The effectiveness and safety of conservative interventions for positional plagiocephaly and congenital muscular torticollis: a synthesis of systematic reviews and guidance, Ellwood J, Draper-Rodi J, Carnes D. Chiropr Man Therap. 2020 Jun 11;28(1):31. doi: 10.1186/s12998-020-00321-w. Full text