Since the advent of recommendations for placing infants in the supine position during sleep to reduce the incidence of sudden infant death syndrome, clinicians have noted an increase in the frequency of cranial asymmetry due to deformation of suture sections of the infants’ skulls as a result of constant concentrated stress in one area at the back of their head. This specific form of cranial deformation is known as positional plagiocephaly and its rate of occurrence has increased from 0.3% in 8.2% within the past 30 years. Current treatments and methodologies for preventing and correcting positional plagiocephaly such as stretching exercises, bedding pillows, and cranial molding are not optimized for effectiveness and comfort. Literature surrounding the implementation of these methodologies or devices often assesses the relative effectiveness of each treatment through statistical means, or studies complications associated with their use. There is a lack of quantified mechanical analysis for determining the effectiveness of each treatment or engineered solutions. In this study, a finite element model was created and validated to study the effect of wearing a cranial helmet, as the most effective non-surgical device for treatment of positional plagiocephaly, on reducing concentrated stress from the back of the baby’s head during sleep. The results from this model were then compared to two other finite element models with a healthy baby sleeping in supine position on a pillow, and a patient diagnosed with a severe case of positional plagiocephaly sleeping on the flat side of his head in supine position. The geometries representing the head of the babies in these models are the refined 3D laser-scanned file of a patient’s head contour at Hanger Clinic as well as the cavity inside the cranial helmet that was used for treatment of the baby. After successfully assigning section and contact properties to different regions of the models, applying proper loading and boundary conditions, and performing mesh convergence studies for each of the three models, the average Von Mises stress values of each of the 13 different suture segments of each model were summarized in tables and evaluated using mathematical and qualitative methods. The stress value data obtained from different suture regions of the model with the cranial helmet resulted in the smallest standard deviation among all three populations which supports that wearing the cranial helmet helps to reduce stress concentrations. Use of the cranial helmet during sleep also showed a significant decrease of the average Von Mises stress within the posterior fontanelle by 90% compared to the healthy baby sleeping in supine position and 73.4% compared to the deformed head sleeping on the flat surface of the head. The major limitations of this study are correlated with the simplifying assumptions and geometries in generating and validating the models. Future studies need to focus on overcoming these limitations and generating more complex models using a similar approach. The methods used in this study and the results obtained from the models can serve as a basis for future development of engineered solutions that are more effective than the existing solutions in the market and reduce the side-effects and complications associated with their use.

Abstract The recommendation for infants to sleep supine has decreased the incidence of sudden infant death syndrome by more than a half, but as another consequence, a dramatic rise has been observed in the incidence of acquired cranial asymmetry (deformational plagiocephaly, DP). According to recent data, almost half of otherwise healthy infants are affected by some degree of DP at 7 to 12 weeks of age, and especially in the USA and some Central European countries, major effort is put into treatment of severe DP. However, little is known of the prognosis of DP in the absence of intervention, and although primary preventive strategies are often recommended, a lack of evidence on the effectiveness of such measures persists. Furthermore, although 3D imaging is nowadays frequently used on infants with DP, no data is available on the accuracy of the measurements used to quantify cranial asymmetry. In the present study, the efficacy of a primary preventive program in reducing the incidence of DP was tested in a randomized, controlled trial. The course of DP in the absence of active treatment was studied throughout the first year of life, and factors impacting the prognosis of DP were investigated. The diagnostic accuracy of four 3D stereophotogrammetry-based measurements was also analyzed and compared, with a goal of determining their optimal cut-off values for DP. DP was less prevalent and less severe in the intervention group infants at the end of the RCT (3 months). The point prevalence of DP peaked at 3 months, whereafter spontaneous improvement in DP was seen throughout the follow-up period until 12 months of age. A preferential infant head position at 3 months was the strongest predictor of a subsequently unfavorable course of DP. Cranial asymmetry seen at birth was transient, and none of the older infants with torticollis had presented neck imbalance at birth, but rather appeared to develop the condition postnatally concomitantly with DP. Although all studied asymmetry-related measurements performed well regarding diagnostic accuracy, OCLR produced the most accurate classification of DP. In conclusion, primary preventive guidelines would likely aid in reducing the burden from both DP itself and associated healthcare costs, although substantial spontaneous improvement from DP can usually be expected. The cut-off values defined for the asymmetry-related measurements have clinical implication in both making the diagnosis of DP and determining the target outcomes for treatment. / Tiivistelmä Imeväisten nukuttaminen selällään on vähentänyt kätkytkuolemien määrää alle puoleen aiemmasta, mutta käytäntö on myös huomattavasti lisännyt asentoperäisen, ei-synostoottisen vinokalloisuuden esiintyvyyttä; tuoreen tutkimustiedon mukaan jopa lähes joka toisella imeväisellä on nähtävissä jonkinasteista asentovinokalloisuutta 7–12 viikon iässä. Etenkin USA:ssa ja muutamissa Keski-Euroopan maissa vaikea-asteista asentovinokalloisuutta hoidetaan aktiivisesti kypäräortoosein, mutta samanaikaisesti tietämys tilan luonnollisesta kulusta on vähäistä. Vaikka riskitekijöitä tunnetaan ja ehkäiseviä toimenpiteitä usein suositellaan, ei niiden tehosta ole juuri näyttöä. Nykyään 3D-pintakuvantamista käytetään usein vinokalloisten imeväisten seurannassa, mutta epäsymmetrian mittaamiseen käytettyjen muuttujien osuvuudesta ei ole tietoa. Tämän tutkimuksen tarkoituksena oli selvittää vastasyntyneiden vanhemmille annettavan vauvan käsittelyohjeistuksen vaikutusta asentovinokalloisuuden ilmaantuvuuteen satunnaistetussa, kontrolloidussa asetelmassa. Lisäksi pitkäaikaisseurannassa kartoitettiin asentovinokalloisuuden luonnollista kulkua ja ennusteeseen vaikuttavia tekijöitä suomalaisilla imeväisillä. Tutkimuksessa myös analysoitiin ja vertailtiin 3D-kuvista laskettavien epäsymmetriaa mittaavien muuttujien diagnostista osuvuutta. Käsittelyohjeita saaneiden lapsilla oli 3 kuukauden iässä merkittävästi vähemmän asentovinokalloisuutta ja kalloasymmetria oli lievempää kuin verrokkiryhmässä. Asentovinokalloisuuden esiintyvyys oli korkeimmillaan juuri 3 kuukauden iässä, jonka jälkeen merkittävää spontaania palautumista oli havaittavissa koko 12 kuukauden ikään jatkuneen seurannan ajan. Vastasyntyneillä nähty kalloasymmetria oli puolestaan ohimenevää, eikä myöskään vastasyntyneenä dokumentoitu kaulan liikerajoitus lisännyt myöhemmän vinokalloisuuden riskiä, vaan vinokalloisilla usein tavattava torticollis (kierokaula) näytti kehittyvän ensimmäisten elinviikkojen aikana yhdessä vinokalloisuuden kanssa. 3 kuukauden iässä havaittu imeväisen halu pitää päätään aina samaan suuntaan käännettynä oli yhteydessä kalloasymmetrian huonompaan spontaaniin palautumiseen. Tutkituista epäsymmetriaa mittaavista muuttujista OCLR erotteli vinokalloiset parhaiten. Yhteenvetona voidaan todeta, että ennaltaehkäisevä ohjeistus voisi vähentää vinokalloisuutta ja siitä aiheutuvia hoitokuluja kustannustehokkaasti, mutta vinokalloisuudelta on lupa odottaa myös merkittävää spontaania palautumista. Tutkimuksessa määritellyillä epäsymmetriaa mittaavien muuttujien raja-arvoilla on käyttöä sekä diagnostiikan että hoidon tavoitteiden määrittelemisen saroilla.