Global Pediatric Health
Volume 5: 1 –11
© The Author(s) 2018
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Brachycephaly is characterized by symmetric, bilateral
flattening of the occiput resulting in a head shape that
becomes disproportionately short and wide. While the
product of the same external forces that cause deforma-
tional plagiocephaly, deformational brachycephaly is
often dismissed as less urgent or significant.1 In particu-
lar, the lack of asymmetry often leads to the incorrect
assumption that brachycephaly is somehow more “cos-
metic” in nature. However, both plagiocephaly and
brachycephaly have been shown to deform the skull
base, affecting the position and orientation of the tem-
poromandibular joints, and affect occlusal function.2-7
Specifically, a brachycephalic deformation of the cranial
vault results in a posterior tipping of the mid cranial
fossa (central skull base) changing the angular orienta-
tion of the temporomandibular joints, and potentially
resulting in Class III malocclusion (underbite).8-13
Anterior displacement of the mandible may also affect
the soft tissue of the upper airway leading to airway
restrictions and obstructive sleep apnea.14-18
Moreover, when the back of the head is flattened, the
center of mass of the head is displaced anteriorly and
superiorly, which, in severe cases, may affect an infant’s
postural control and postural alignment.19,20 While the
muscular imbalance and restricted range of motion (ie,
torticollis, or lateral/rotational imbalance) frequently
associated with plagiocephaly is commonly discussed,
the muscular imbalance of brachycephaly (what we’ll
call AP imbalance) has largely gone unrecognized. As
the center of mass shifts, the anterior neck muscles
become shortened while the extensor neck muscles get
lengthened leading to an imbalance of the flexor/exten-
sor muscle groups. This imbalance leads to poor
805618GPHXXX10.1177/2333794X18805618Global Pediatric HealthKelly et al
1University of Iowa, Iowa City, IA, USA
2Barrow Cleft and Craniofacial Center, Phoenix, AZ, USA
3Southwest Craniofacial Center, Phoenix, AZ, USA
4Cranial Technologies, Tempe, AZ, USA
Timothy R. Littlefield, Cranial Technologies, Inc, 1395 West Auto
Drive, Tempe, AZ 85248, USA.
Helmet Treatment of Infants With
Kevin M. Kelly, PhD1, Edward F. Joganic, MD, FACS2,
Stephen P. Beals, MD, FACS, FAAP3, Jeff A. Riggs, MA4,
Mary Kay McGuire, OTR/L4, and Timothy R. Littlefield, MS4
Deformation of the cranium in infancy represents a spectrum of deformity, ranging from severe asymmetric
yet proportional distortion of the skull in plagiocephaly, to nearly symmetric yet disproportional distortion in
brachycephaly. As such, the condition is best described as deformational plagiocephaly-brachycephaly with isolated
plagiocephaly and/or isolated brachycephaly being at either ends of the spectrum. Due to its symmetric appearance,
deformational brachycephaly is often incorrectly dismissed as being less concerning, and it has sometimes erroneously
been reported that brachycephaly cannot be treated successfully with a cranial orthosis. We prospectively report
on 4205 infants with isolated deformational brachycephaly treated with a cranial orthosis from 2013 to 2017. These
results demonstrate that the orthosis is successful in the treatment of deformational brachycephaly with an 81.4%
improvement toward normal (95.0 to 89.4) in cephalic index. We furthermore demonstrate that entrance age
influences treatment results, with younger infants demonstrating both improved outcomes and shorter treatment
deformational brachycephaly, cranial orthosis, flat head syndrome, cephalic index
Received July 2, 2018. Received revised August 9, 2018. Accepted for publication August 28, 2018.
2 Global Pediatric Health
postural stability, with the shorter anterior muscles able
to react faster than the lengthened extensor groups. This
poor postural stability affects the efficiency of move-
ment, and infants will tend to either posture with the
chin flexed and trunk rounded or hyperextend the neck
and elevate the shoulders (ie, park the head) in order to
stabilize and maintain balance.19-23 These postures cause
less variability in the infant’s movement, which limits
their interaction with their environment.
Recently, the potential relationship between severe
deformational brachycephaly and hindbrain herniation,
due to the reduction in posterior cranial fossa volume,
has been discussed,24,25 although this has not yet been
investigated extensively. Additionally, one of the imme-
diate concerns of deformational brachycephaly is its
impact on the fit of protective equipment. In brachy-
cephaly, the head is disproportionally wider, shorter, and
often taller than the average head for that age. It is not
uncommon for parents to report having to purchase
adult-sized helmets in an attempt to accommodate for
the increased width of their child’s or adolescent’s head,
but then discovering that the helmet tends to tip into the
child’s face. When considering the number of athletic
and recreational activities that now require the use of
protective helmets, this is no small consideration and
affects not only the child’s participation, but also how
well they are protected during the activity.
While the treatment of plagiocephaly has received
considerable attention (see Flannery et al26 for a recent
review), only 2 studies27,28 have specifically addressed the
treatment of brachycephaly. This study was undertaken to
prospectively examine the effects of helmet treatment of
isolated deformational brachycephaly and to investigate
the role of 3 key treatment factors (entrance age, treat-
ment time, and initial severity) on treatment outcome.
Materials and Methods
Study subjects were identified from among a cohort of
infants who have been registered in a central clinical
research database since January 2013. Briefly, the data-
base contains information on all infants referred by their
primary physician for consultation at any of 30 clinic
locations through the Unites States. This cohort includes
infants with abnormal head shape diagnoses of all types
(synostotic and nonsynostotic), forms (plagiocephaly,
brachycephaly, dolichocephaly), and severity levels
(mild to severe). Data include demographic and assess-
ment information as well as a detailed medical history
regarding the well-established risk factors previously
reported.29-31 Quantifiable information regarding the
infant’s cranial shape is obtained using a 3-dimensional
(3D) imaging system previously documented else-
where32,33 (Figure 1). The accuracy of both the 3D image
acquisition, as well as software measurement functions,
have been previously validated to be within ±0.5
Patient data from the period January 2013 through
December 2017 (5 years; 128 014 patients) were evalu-
ated. The study population comprised 4205 infants (3.2%
of the total patient population) treated for isolated defor-
mational brachycephaly. Study subjects had complete
records at entry into and exit from treatment, moderate to
severe brachycephaly as previously described27,28 (ie, a
cephalic index [(Cranial Width/Cranial Length) × 100] ⩾
90), normal or minimal asymmetry (specifically, cranial
vault asymmetry, midface asymmetry, skull base asymme-
try ⩽3 mm), and had entered into treatment between 3 and
12 months of age. All infants began treatment within 3
Figure 1. Digital Surface Imaging. Image shown in (a) photographic, (b) solid, and (c) wireframe.
Kelly et al 3
weeks of their initial treatment consultation for a cranial
remodeling orthosis described elsewhere.35-37 Patients
with confounding medical conditions (≈ 0.9%; eg, synos-
tosis, syndromic conditions, surgical shunt) were excluded
from the analyses. The study protocol was approved by an
external independent review board (Argus IRB, Tucson,
AZ). Informed consent was obtained for all participants.
To more easily visualize the effects of treatment age on
treatment outcome, the study population was divided
into 3 groups based on entrance age into treatment.
Group 1 entered treatment between ⩾3 months and <6
months of age, Group 2 entered treatment between ⩾6
months and <9 months, and Group 3 entered treatment
between ⩾9 months and ⩽12 months of age. These
groups were selected based on popular thresholds
established in the literature, and for the purpose of
allowing comparison to other previously published
studies.27,28 Descriptive statistics for all treatment vari-
ables in aggregate and by treatment group are reported
in Table 1.
All statistical analyses were performed using SAS
software.38 Group differences in sex ratio were evalu-
ated using χ2 test (SAS PROC FREQ38). Analysis of
variance (SAS PROC GLM using the DUNCAN
MEANS option to assess differences among group
means38) was performed to evaluate differences among
groups with regard to parametric variables as well as to
identify how key treatment parameters (age of treat-
ment, treatment time, and initial cephalic index) contrib-
uted to treatment outcome.
A total of 4205 infants were studied in this investigation
(Table 1). Mean entrance age was 5.8 months with a
mean treatment time of 13.5 (±5.7) weeks. Over the
treatment period, circumference increased an average of
18.7 mm (±7.6), from 433.6 mm to 452.3 mm. Mean
cranial width began at 130.7 mm (±6.1) and increased
marginally to 132.5 mm (±6.2), a change of only 1.8
mm (±2.7) indicating that biparietal width was held as
intended. Conversely, the cranial length increased from
137.6 mm (±6.4) to 148.2 mm (±5.9), a change of 10.5
mm (±3.5). The result was a mean overall cephalic
index reduction of 5.6% (95.0% at treatment entry to
89.4% at treatment exit, representing an 81.4% improve-
ment toward normal; Table 1).
Moreover, by cross-classifying the infants by their
initial and final severities (Table 2), we can examine
how the infants responded to treatment. Of the 4205
infants in this investigation, 2921 (69.5%) infants began
treatment initially classified as having severe brachy-
cephaly. Of those, 17.4% (509/2921) finished treatment
in the normal category; 27.3% (799/2921) finished as
mild; 39.6% (1156/2921) were moderate; with only
15.6% (457/2921) remaining in the severe category.
Another way of reporting this is that, of the 2921 infants
initially classified as having a severe deformity at the
initiation of treatment, 84.4% (2464/2921) were no
Table 1. Relevant Treatment Parameters by Age of Entry Into Treatmenta.
Parameter All, N = 4205 ⩾3 to <6, n = 2485 ⩾6 to <9, n = 1531 ⩾9 to ⩽12, n = 189
Consult age (months)*** 5.4 (±1.5) 4.4 (±0.6) 6.5 (±0.7) 9.6 (±0.8)
Entry age (months)*** 5.8 (±1.5) 4.8 (±0.6) 6.9 (±0.7) 10.0 (±0.8)
Treatment time (weeks)*** 13.5 (±5.7) 11.9 (±5.4) 15.8 (±5.3) 17.4 (±4.3)
% Male not significant 62.8% 63.3%#62.7%#57.7%#
Initial cranial index (CI)** 95.0 (±3.2) 95.1 (±3.3) 95.0 (±3.0) 94.3 (±3.1)
Exit CI*** 89.4 (±2.8) 89.3 (±2.9) 89.6 (±2.8) 90.0 (±2.7)
Change in CI*** −5.6 (±2.3) −5.8 (±2.3) −5.4 (±2.2) −4.3 (±1.8)
Initial circumference (mm)*** 433.6 (±18.3) 426.1 (±15.3)c443.1 (±16.2)c455.7 (±17.2)
Exit circumference (mm)*** 452.3 (±17.9) 446.6 (±16.5)c459.7 (±16.2)c468.2 (±17.0)
Change circumference (mm)*** 18.7 (±7.6) 20.4 (±7.9) 16.6 (±6.4) 12.6 (±5.8)
Initial cranial width (mm)*** 130.7 (±6.1) 128.3 (±5.2) 133.7 (±5.5) 136.5 (±5.9)
Exit cranial width (mm)*** 132.5 (±6.2) 130.6 (±5.7) 134.9 (±5.7) 137.7 (±5.8)
Change cranial width (mm)*** 1.8 (±2.7) 2.2 (±2.7) 1.2 (±2.5) 0.1 (±2.3)
Initial cranial length (mm)*** 137.6 (±6.4) 135.0 (±5.2) 140.8 (±5.5) 146.0 (±5.9)
Exit cranial length (mm)*** 148.2 (±5.9) 146.3 (±5.5) 150.6 (±5.5) 153.0 (±5.7)
Change cranial length (mm)*** 10.5 (± 3.5) 11.3 (±3.5) 9.8 (±3.0) 7.0 (±2.7)
aFor overall group differences: ***P < .0001; **P < .001. For group-wise comparisons: means with “#” are not significantly different. Other
pairwise comparisons (ie, unmarked group statistics) are significant at the .05 level.
4 Global Pediatric Health
Table 2. Pretreatment Versus Posttreatment Classification of Severity.
Pretreatment Classification Posttreatment Classification
Total Normal (⩽88) Mild (>88 to ⩽90)
to ⩽93) Severe (>93)
Mild (=90) 26 (0.6%) 22 (0.5%) 4 (0.1%) 0 (0.0%) 0 (0.0%)
Moderate (>90 to ⩽93) 1258 (29.9%) 868 (20.6%) 335 (8.0%) 557 (1.3%) 0 (0.0%)
Severe (>93) 2921 (69.5%) 509 (12.1%) 799 (19.0%) 1156 (27.5%) 457 (10.9%)
Total 4205 (100.0%) 1399 (33.3%) 1138 (27.1%) 1211 (28.8%) 457 (10.9%)
Figure 2. Female infant starting treatment at 4 months of age; initial cephalic index: 98.5; exit cephalic index: 89.3; treatment
time 2¾ months (grid units 20 mm).
Kelly et al 5
longer in that category at the end of treatment, with
nearly half, 44.8% (1308/2921), having been returned to
a “normal-to-mild” classification. In totality, 60.3%
(2537/4205) ended treatment with a “normal-to-mild”
classification (Figure 2). Overall, 87.7% of the infants
(3689/4205) demonstrated improvement in cephalic
index following treatment with a cranial orthosis; 3948
infants (92.9%) having been treated with only one
Table 3. Results of Analysis of Variance for Treatment Variables Showing Differences by Treatment Groupa.
3 to <6 Months
6 to <9 Months
9 to 12 Months
of Age F P
Initial cephalic index (CI) 95.1#95.0#94.3 5.34 .0048
Treatment time 11.9 15.8 17.4 300.34 <.0001
Change in CI −5.8 −5.4 −4.3 48.85 <.0001
aFor groupwise comparison: means with “#” are not significantly different. Other pairwise comparisons are significant at the .05 level.
Figure 3. Mean treatment time by group (with 1 standard deviation bars).
Figure 4. Mean change in cephalic index by group (with 1 standard deviation bars).
6 Global Pediatric Health
cranial orthosis. In no case did the condition worsen.
With the exception of a low incidence (0.91%) of skin
irritation (red spots, skin breakdown, heat rash), no sig-
nificant issues were reported.
To explore the effects of age on treatment, the sam-
ple was stratified into 3 equal interval treatment ranges
(⩾3 to <6 months; ⩾6 to <9 months; ⩾9 to ⩽12
months; Tables 1 and 2). Although the mean entrance
Figure 5. Male infant entering treatment at 3¾ months of age; initial cephalic index: 102.3; exit cephalic index: 90.5;
treatment time 3.25 months.
Figure 6. Male infant entering treatment at 8 months of age; initial cephalic index: 102.9; exit cephalic index: 91.1; treatment
time 9.5 months.
Kelly et al 7
cephalic index was not statistically significant different
between the groups (95.1, 95.0, 94.3; Table 3), treat-
ment time was significantly longer (11.9 weeks, 15.8
weeks, 17.4 weeks; Table 3 and Figure 3) and treat-
ment changes significantly smaller (5.8, 5.4, 4.3; Table
3 and Figure 4) moving up in age cohort. As would be
anticipated from the pediatric cranial growth charts,
mean change in circumferential growth also decreased
with entrance age (20.4 mm, 16.6 mm, 12.6 mm; Table
1), and this despite the longer treatment times docu-
mented for the older groups. Therefore, although the
initial deformity was not significantly different across
the age groups, infants treated prior to 9 months of age
received significantly greater improvements than chil-
dren treated at 9 months of age or later. Moreover, chil-
dren treated at earlier ages had significantly shorter
treatment times than those in subsequent treatment
groups (Figures 5 and 6).
Analysis of variance was also used to partition the
variation observed among set observations into portions
associated with certain factors. For example, variation in
improvement in cephalic index can be partitioned into
factors associated with “initial cephalic index,” “treat-
ment time,” and “age at entry into treatment” (Table 4).
The 2 intuitively obvious findings were that greatest
change in cephalic index could be achieved (a) in those
infants who initially presented with the most severe defor-
mities (ie, had the largest initial cephalic index), and (b)
by treating any infant (regardless of severity) for a longer
period of time. However, the more interesting and clini-
cally meaningful findings were that the younger the infant
entered treatment (c) the shorter their treatment duration,
and (d) the greater their reduction in cephalic index.
Although the American Academy of Pediatrics’ “Back
to Sleep (BTS)” campaign is frequently cited as the
reason for the recent increase in cranial deformities,
other factors—most notably, devices of convenience—
also contribute. Today infants spend extended periods
of time in devices including infant swings, bouncy
seats, carriers, and car seats.39 Although not always
appreciated, these devices result in cranial deforma-
tion that are similar to those produced by the cradle
boards used by several Native American Indian
tribes.40,41 In fact, Davis et al42 have documented that
infants from the ages of 0 to 3 months (a critical age in
the development of plagiocephaly/brachycephaly)
spent ~23 hours/day in a supine-like position. Today
the American Academy of Pediatrics, as well as many
other organizations, now advise parents to limit the
time infants spend in car seats and other devices of
Correction of Deformational Brachycephaly
While the treatment of deformation brachycephaly has
received limited attention, both previously published
studies27,28 reported significant correction of the defor-
mation (Table 5). In particular, in the only other treat-
ment study to have focused exclusively on deformational
brachycephaly, Graham and colleagues28 report signifi-
cant correction of deformational brachycephaly. Among
a subgroup of infants who—in common with the current
study—initiated treatment with a cephalic index ⩾90%
(n = 92), Graham and associates observed a mean
reduction in cephalic index of 4.2% (from 96.1% to
Table 4. Results of Analysis of Variance for the Effects of Treatment Variables on “Change in Cephalic Index” Using the Type
III Sum of Squares to Partition Their Contribution.
Parameter Type III Sum of Squares F P
Initial cephalic index 3729.31 1038.54 <.0001
Treatment time 747.90 208.28 <.0001
Entry age 886.27 246.81 <.0001
Table 5. Deformational Brachycephaly Study Comparisons.
Parameter Teichgraeber (2004)27 Graham (2005)28 Kelly (Current)
Sample size (n) 64 92 4205
Mean initial cephalic index 93.7% 96.1% 95.0%
Mean end cephalic index 90.9% 91.9% 89.4%
Mean change in cephalic index 2.8% 4.2% 5.6%
Treatment time 4.5 months 3.7 months 3.4 months
8 Global Pediatric Health
Teichgraeber et al27 reported that helmet treatment
produced favorable outcomes for infants with both
deformational brachycephaly as well as deformational
plagiocephaly; however, they noted that “the head
shapes of the children with positional brachycephaly did
not normalize despite statistically significant improve-
ment in their cephalic index . . . ,” concluding that “. . .
helmet therapy is more effective in children with poste-
rior positional plagiocephaly than in children with posi-
However, it should be noted that the challenge of
returning a brachycephalic head to within normal limits
lies in the observation that once an infant’s head has
obtained a certain width, there is no way to reduce this
dimension. By design, cranial orthotic devices do not
compress the head and therefore cannot make a head any
narrower; all that can be achieved is to redirect future
growth in the anteroposterior dimension. Additionally,
in severe cases, where the occipital bone has been
allowed to become nearly perfectly flat, it is difficult to
restore the natural occipital curve. Instead, increased
posterior growth will often result in lengthening to the
cranium and improved cephalic index, yet from a lateral
perspective, the occipital profile may still appear flat.
Hence, an argument could be made that intervention
prior to this level of deformity is warranted, both from a
treatment outcome as well as a preservation of posterior
cranial volume perspective.
Influence of Entrance Age on Outcome
Although Teichgraeber et al27 found that “the age at
which therapy was begun did not have an impact on the
final results,” they further note that “these results do not
correlate with what is seen clinically . . . ,” suspecting
that the “discrepancy between the data and the authors’
clinical experience may be a result of having arbitrarily
divided the children into 2 subgroups and the small
numbers of children in both of these subgroups.”27
Consistent with our findings, Graham et al28 found an
inverse correlation between entrance age and outcome.
For infants beginning treatment between 3.0 and 4.5
months of age, reduction in cephalic index was 5.1%;
for infants 4.5 to 6.0 months of age, it was 3.2%; and for
infants entering treatment later than 6 months, reduction
in cephalic index was 2.9%. These results mirror the
findings of other investigators who have previously
reported on the positive impact of early entrance age on
the effectiveness of the cranial orthosis37,44-52 (Table 6).
The key message from these observations is that
brachycephaly, just like plagiocephaly, should not be
allowed to progress to a severe classification before
intervention is started. Conservative efforts such as
supervised tummy time, repositioning, and limiting time
in devices of convenience should be initiated as soon as
a widening of the head is observed. If after 6 to 8 weeks
of these efforts the head is continuing to become more
brachycephalic, use of a cranial orthosis may be war-
ranted in order to leverage—as we have demonstrated
here—the benefits of early intervention that include
improved outcomes and shorter treatment times.
As with all studies, it is important to acknowledge the
limitations of the work presented so that future investi-
gators may be aware, and critically review the content in
light of these weaknesses. The most immediate limita-
tion is that this is not, nor was it designed to be, a ran-
domized control trial. While many authors have
previously discussed why execution of a randomized
control trial may be difficult or even ethically question-
able,52-54 it was simply not within our scope to be able to
perform. As a medical treatment provider, patients are
sent by physicians who have diagnosed and monitored
their patients and have prescribed treatment based on
their dissatisfaction with the progression of head shape.
The use of linear anthropometric measurements to
describe changes in a complex 3D head shape is also a
limitation of this study. Although there is a high degree
of confidence in the repeatability and reliability of
these measurements, linear measurements can only
convey so much information.55 This was why we chose
to provide so many figures illustrating the correction
that may be achieved, as these figures demonstrate the
clinically significant change in curvature, volume, and
shape that are sometimes difficult to appreciate with
just a few percentage point changes in cephalic index.
Several studies have now reported on the use of 3D
data in the form of root mean square calculations, and
we applaud the authors in those efforts and feel this is
the direction that future investigations must go.56,57
However, in the case of studies on proportionality,
Table 6. Deformational Brachycephaly Study Change Comparisons by Age Group.
Age at Treatment
Initiation Teichgraeber (2004)27 Graham (2005)28 Kelly (Current)
3.0 to 4.5 months 2.8% 5.1% 5.8% 5.8%
4.5 to 6.0 months 3.2% 5.8%
⩾6.0 to <9.0 2.6% 2.9 % 5.2% 5.4%
Kelly et al 9
such as in deformational brachycephaly, the root mean
square measure is a less useful measurement.
Furthermore, the cephalic index is a well-established,
reproducible value that is well understood by the medi-
cal community, and in using this measure, it allowed us
to make direct comparisons to other previously pub-
lished studies on this subject.
As discussed, deformation of the cranium in infancy
represents a spectrum of deformity, ranging from severe
asymmetric yet proportional distortion of the skull in
plagiocephaly, to nearly symmetric yet disproportional
distortion in brachycephaly. As such, the condition is
best described as deformational plagiocephaly-brachy-
cephaly with isolated plagiocephaly and/or isolated
brachycephaly being at either ends of the spectrum.58,59
This investigation demonstrates that the cranial ortho-
sis is successful in the treatment of deformational brachy-
cephaly. These findings are consistent with the only other
2 published studies specifically looking at deformational
brachycephaly as a separate entity from deformational
plagiocephaly. It has also been demonstrated that
entrance age is a critical variable in the overall effective-
ness of treatment with younger infants demonstrating
both improved outcomes and shorter treatment times,
regardless of the severity of the presenting deformity.
When considering the mechanics of how a cranial
orthosis works (ie, holding the prominences and redi-
recting brain growth into the adjacent flattened areas), as
well as a basic understanding of normal craniofacial
growth patterns of the infants from birth to 12 months of
age, it may be recognized that the treatment of deforma-
tional brachycephaly in many ways is no different than
the treatment of deformational plagiocephaly. All that
has changed is the direction in which the corrective
forces are applied, from a contralateral pattern in plagio-
cephaly to a lateral pattern in brachycephaly. The rest is
accomplished by growth of the brain and proper adjust-
ment of the product by the treating clinician.
A preliminary portion of these data were included in the book
Smith’s Recognizable Patterns of Human Deformation, 4th
edition, by Graham JM and Sanchez-Lara P, and cited as
unpublished data (eBook ISBN: 9780323295383; Hardcover
The authors would like to thank the members of the Image
Processing Department for their dedication and countless
hours of assistance and for whom without which this study
would not have been possible, as well as Brody Kilgore,
engineering intern with Arizona State University, for his
assistance in programing and querying the SQL database
containing the patient records utilized in this study. We
would also like to thank Canfield Scientific for their assis-
tance in developing the standardization and automation of
the measurement functions, and for providing study results
validating the accuracy of the software applications.
KMK participated in the conceptualization and design of the
study, performed all statistical analysis, and reviewed, revised
and approved the final manuscript as submitted.
JAR developed the DSi Analysis reports; developed, pro-
grammed and maintained the Excel/SQL databases; and
reviewed and approved the final manuscript as submitted.
EFJ reviewed the design of the study and, reviewed and
approved the final manuscript as submitted.
SPB reviewed the design of the study and, reviewed and
approved the final manuscript as submitted.
MKM provided insight into the developmental impact of
brachycephaly and concerns being raised in the physical and
occupational therapy communities, and reviewed and approved
the final manuscript as submitted.
TRL conceptualized and designed the study, submitted the
IRB approval, trained the individuals and verified the accuracy
of the anthropometric measurements, and approved the final
manuscript as submitted.
The study protocol was approved by an external independent
review board (Argus IRB, Tucson, AZ; CF#02_01).
Declaration of Conflicting Interests
The author(s) declared the following potential conflicts of
interest with respect to the research, authorship, and/or publi-
cation of this article: Mr Littlefield, Mr Riggs, and Ms McGuire
are employees of Cranial Technologies, Inc. The remaining
authors have no financial or commercial interest.
The author(s) received no financial support for the research,
authorship, and/or publication of this article.
Informed consent was obtained for all participants.
Kevin M. Kelly https://orcid.org/0000-0002-9177-1454
Timothy R. Littlefield https://orcid.org/0000-0002-8262
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