| Since the American Academy of Pediatrics
1992 recommendation that, to avoid sudden infant death, infants
no longer be placed prone to sleep, babies have increasingly
been referred to neurosurgeons for flattening of the occiput,
or occipital plagiocephaly. This condition is also known as
posterior deformational plagiocephaly, or positional molding.
It is by definition non-synostotic, as it results not from a
prematurely-closed suture but from positioning the child supine
or prenatal constrictive forces on the head within the uterus.
Once flattened on one side or the other, the head tends to roll
to that side, and maintain the deformity. Associated subsequent
facial deformities include prominence of the ipsilateral forehead,
anterior displacement of the ipsilateral ear, and prominence
of the ipsilateral malar eminence. Occipital plagiocephaly has
traditionally been treated by actively changing the baby's sleeping
position, along with physical therapy. Frequently, the use of
a contouring helmet has been added to this regimen, until the
baby's head shape becomes symmetric. Success in reshaping the
head has been reported with both approaches, but there have
been no prospective, randomized studies comparing the use of
the helmet to positional changes and physical therapy alone.
Accordingly, third-party insurance payers are frequently reluctant
to pay for the helmet, which, although shown in numerous studies
to be effective, has not been demonstrated to be superior to
positional and physical therapy in a prospective, randomized
trial. The aims of the study are therefore: (1) To determine
whether there is any difference in the outcome of occipital
plagiocephaly with the use of molding helmets in addition to
positional and physical therapy; (2) To determine if plain skull
radiographs are adequate to distinguish between synostotic and
non-synostotic plagiocephaly, or if computed tomography is necessary
to make the diagnosis.
The study population currently includes 50 infants between
the ages of 0 and 6 months of age, diagnosed with non-synostotic
occipital plagiocephaly. The diagnosis will be made by clinical
examination, plain skull radiographs (Townes and lateral views),
and 3-dimensional CT. Parents will give informed consent for
participation in the study. The patients will be randomized
to either a helmet group or a non-helmet group. Measurements
of head width at the widest point (eu-eu), temple-temple forehead
width (ft-ft) to skull base index, head circumference, and
diameters of the long vs. short axes of the head will be taken
initially, after 2 months of treatment, after 6 months of
treatment, and after an additional 1 year of follow-up (18
months after enrollment in the study). Measurements will be
taken with sliding calipers, measuring tape, and CT. The same
measurements will be taken of 60 normocephalic infants ages
0-6 months for comparison. These normal infants will be children
born full-term at Hutzel Hospital, without any perinatal problems.
They will not undergo any radiographic studies, and their
hospital stay will not be prolonged for the taking of skull
measurements. However, they will be seen again and have cranial
measurements taken at their scheduled well-baby visits (18
months). Three-dimensional CT will be performed on the plagiocephalic
patients initially and after 18 months to assess changes in
skull base angulation and asymmetry. The patients in the helmet
and non-helmet groups will receive identical courses of physical
therapy, and these parents will be instructed to keep the
child's head positioned on the contralateral side when supine.
Children with torticollis will receive cervical spine xrays
to rule out vertebral abnormalities, as well as ophthalmologic
evaluation for trochlear nerve palsy. If a patient randomized
to the non-helmet or no-treatment arms shows a worsening head
shape after 2 months, he/she will be changed to the helmet
group. They will then be seen 1 year later for follow-up and
post-treatment CT. Patient (parent) and surgeon satisfaction
will be recorded at that time as 1) Very satisfied, 2) Somewhat
satisfied, or 3) Unsatisfied. The 6-month data are currently
being analyzed.
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