Objective: This study aimed to investigate the impact of helmet therapy on changes in cranial asymmetry of infants with positional
cranial deformities and to identify clinical and morphometric factors associated with treatment outcome.
Design: This retrospective monocentric cohort study included 455 infants treated between 2011 and 2021.
Setting: Data were collected using manual measurements in a tertiary care setting within the outpatient clinic of a maxillofacial
surgery department in Germany.
Patients: Infants with positional cranial deformities, including plagiocephaly, brachycephaly, and combined types, were included.
Intervention: All patients were treated with a helmet orthosis, and data were analyzed to assess changes in cranial measurements
and associated factors.
Main Outcome Measures: Predefined outcome thresholds based on cranial asymmetry reduction and prognostic factors.
Results: Plagiocephaly was the most common deformity in 332 infants. Increased ear shift (Exp(B) =0.199; 95% CI: 0.087–0.451;
p ≤ .001) and large initial diagonal difference (Exp(B) =0.518; 95% CI: 0.334–0.802; p=.003) were correlated to unfavorable outcome.
Delayed treatment was associated with lower reduction in diagonal difference (rs =–0.229; p ≤ .001), and recognized as a
negative prognostic factor (Exp(B) =0.993; 95% CI: 0.989–0.997; p ≤ .001). In contrast, a higher baseline cranial index increased
the probability of success (Exp(B) =1.057; 95% CI: 1.030–1.084; p ≤ .001).
Conclusion: Early diagnosis and intervention are crucial for effective treatment of cranial deformities with helmet orthosis,
especially in cases with ear shift or severe initial deformation.