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The CONS of helmet therapy for

Peter D. Ray, MD Associate Professor MUSOM How Common is Positional Skull Deformity?

The incidence of positional skull deformity has been estimated to be as low as 1 in 300 live births to as high as 48% of typical healthy infants younger than 1 year, depending on the sensitivity of the criteria used to make the diagnosis.

Diagnosis is by history and physical exam

Peak prevalence is at age 4 months Since the American Academy of Pediatrics Task Force on Infant Positioning and Sudden Infant Death Syndrome (SIDS) in 1992 recommended that healthy infants be positioned supine for sleeping, the incidence of SIDS has decreased from 1.2 per 1000 live births in 1992 to 0.56 per 1000 live births in 2001.

Coincident with this decrease in SIDS has been a drastic increase in positional skull deformity, estimated at approximately 13% in healthy singleton infants, which makes this a relatively common issue to be faced by the pediatrician caring for infants and their families. Twenty years ago….

1992 - Back To Sleep Program

1995 - 3% rose to 20% lambdoid Fetal skull is easily deformed

Flexible and expansil

Rapid growth before 6 months

By 12 months 85% of the adult size

Ossification by age 8

Bone union by age 20 Methods of Prevention of Deformational Plagiocephaly

Donut shaped head supports

Bed placement variation

No surgical treatment needed

40% of newborns Skull rate of growth tapers

HC velocity of growth

3 months - 2 cm per month

4-6 months - 1 cm per month

Over 6 month - .5 cm per month

Helmeting restricts the normal and allows the abnormal to grow

Cranial orthosis Risk factors

Familial

Breech

Oligohydramnios

Multiple births How to examine?

Rule out

- Torticollis - Rotating Stool test - child faces parent and clinician rotates in the stool - How to examine?

Rule out

- Torticollis - Rotating Stool test - child faces parent and clinician rotates in the stool - Craniosynostosis

CAVEAT Lambdoid Suture

The incidence of isolated lambdoid craniosynostosis is quite rare, estimated to be approximately 3 in 100 000 births (0.003%). - Plagio- Gk. for “oblique”

- Brachy - Gk. for “short”

- Dolicho - Gk. “long” and “narrow”

How Available is Helmeting?

Only a few universities in the U.S. have programs for orthotics; these programs must meet stringent criteria set by the American Board for Certification in Orthotics, Prosthetics, and Pedorthotics.

Once an orthotist finishes the formal educational portion of training, he or she begins a residency program under the supervision of a certified practitioner to gain practical experience.

A year's experience and references are required before the resident can submit an application to take both a written and a practical examination. When a resident passes the exam he can use the credentials of C.O. (certified orthotist), so it is important for parents to check that the orthotist their child is seeing is a C.O.

Similar to Ultrasound idea that the person is most important (art and science and dedication) What else affects outcome?

The earlier a child is diagnosed with positional plagiocephaly and started on helmet therapy, the shorter the period of wear and the higher the chance of achieving full correction of the asymmetry.

Babies referred for helmets at a later age (e.g., 6-8 months), or after having failed to improve with conservative treatments, can still get helmets, but they may have to wear them for a longer period of time than if they had started at a younger age.

Helmets are not effective once brain growth is complete. Three quarters of brain growth occurs by age 2.

Uncorrected plagiocephaly will not influence a child's neurological development, but it can affect a child's social well-being later in life. Surgery is not needed

Positional skull deformities are generally benign, reversible head-shape anomalies that do not require surgical intervention

This common condition has been referred to by many names such as benign positional molding, posterior plagiocephaly, occipital plagiocephaly, plagiocephaly without synostosis, and deformational plagiocephaly.

If the infant continues to rest his or her head on the flattened side of the occiput, an initially occipital plagiocephalic deformity may be perpetuated or worsened by gravitational forces STAR Scanner

Insurance Issues As you might expect, it is difficult to make any definitive statements about insurance coverage, because so much depends on individual policies, coverage and companies.

That being said….

PURLs: helmets for positional skull deformities: a good idea, or not?

Rowland K1, Das N2.

J Fam Pract. 2015 Jan;64(1):44-6.Abstract Probably not. Helmets appear to be no more effective than waiting for natural skull growth to correct the shape of an infant's head.

PMC4294410 Helmet therapy in infants with positional skull deformation: randomised controlled trial.

- Natural course vs. helmet therapy - Infants 5-6 months of age - Single blinded - Randomized - Controlled nested study in prospective cohort - Born at 36 weeks gestation - No torticollis, craniosynostosis, or deformities - 84 infants - 29 physiotherapy offices, 4 specializing in helmet therapy

van Wijk RM1, van Vlimmeren LA, Groothuis-Oudshoorn CG, Van der Ploeg CP, Ijzerman MJ, Boere-Boonekamp MM. BMJ. 2014 May 1;348:g2741. doi: 10.1136/bmj.g2741 RCT: Helmet or not?

Measures

- 6 months of helmet therapy - Primary outcome - Oblique diameter difference index (ODDI) - Cranio-proportional index (CPI) - Secondary outcome - Ear deviation - Facial Asymmetry - Occipital Lift - Motor Development - Quality of Life - Parental Satisfaction and Anxiety RCT: Helmet or not?

RESULTS: The change score for both plagiocephaly and was equal between the helmet therapy and natural course groups, with a mean difference of -0.2 (95% confidence interval -1.6 to 1.2, P=0.80) and 0.2 (-1.7 to 2.2, P=0.81), respectively.

Full recovery was achieved in 10 of 39 (26%) participants in the helmet therapy group and 9 of 40 (23%) participants in the natural course group (odds ratio 1.2, 95% confidence interval 0.4 to 3.3, P=0.74).

All parents reported one or more side effects.

The ratio between the sinistra-dextra (SD) and the anterior-posterior (AP) is calculated as SD/AP x 100%, and is called the cranio proportional index (CPI)

The oblique diameter left (ODL) and oblique diameter right (ODR) lines are drawn from points located 40 degrees either side of the antero-posterior (AP) line. ... The ratio between ODL and ODR is calculated as the longest/shortest diameter x 100%, and is called oblique diameter difference index (ODDI).

FACTS

Although there have been no rigorous prospective studies to address this concern, there is currently no evidence to suggest that positional skull deformity causes developmental delays

There has been no credible medical evidence to support concerns brought up in lay literature associating positional skull deformity to otitis media, temporomandibular (TMJ) syndrome, , or dislocation.

Concerns have been raised over vision development and mandibular asymmetry, but a causal link to positional skull deformity has not been established FACTS

A certain amount of prone positioning, or “tummy time,” while the infant is awake and being observed is recommended to help prevent the development of flattening of the occiput and to facilitate development of the upper girdle strength necessary for timely attainment of certain motor milestones.

Beginning at birth, most positional skull deformity also can be prevented

- nightly alternating the supine head position (ie, left and right occiputs) during sleep

- periodically changing the orientation of the infant to outside activity (i.e, door)

Prolonged placement indoors in car safety seats and swings should be discouraged.

Documentation of these educational discussions and notation of infants' positive physical findings longitudinally are important. RCT: Helmet or not?

CONCLUSIONS: Based on the equal effectiveness of helmet therapy and skull deformation following its natural course, high prevalence of side effects, and high costs associated with helmet therapy, we discourage the use of a helmet as a standard treatment for healthy infants with moderate to severe skull deformation.