Résumé
Cranial positional deformities occur frequently in the first months of life.
To evaluate the effectiveness of osteopathic manipulative treatment (OMT) in preventing the onset of positional plagiocephaly and brachycephaly at 4 months in at-risk newborns.
This single-center, randomized, controlled open-label study, with blinded assessment of the endpoints, was carried out at the maternity unit of Montpellier University Hospital (France) between 2019 and 2022. Newborns aged between 3 and 10 days with at least one risk factor for cranial deformity were included and randomized into a group receiving OMT in addition to advice for the prevention of cranial deformities or a group receiving advice alone (standard care). OMT included an osteopathic assessment, osteopathic treatment, and at least one follow-up session. The primary outcome was the occurrence of plagiocephaly (cranial asymmetry index ≥106 %) or brachycephaly (cranial index ≥93 %) at 4 months after birth.
The trial terminated early due to enrolment issues (56.1 % of planned recruitment). Among the 101 patients included, 35 in the OMT group and 30 in the control group completed the study and were analyzed. At 4 months, no significant difference was observed in the rates of brachycephaly (relative risk [RR] of the control group vs. OMT: 1.55, 95 % confidence interval [CI]: [0.38, 6.39], p = 0.54), or plagiocephaly (RR=1.64, 95 % CI [0.34, 8.00], p = 0.54). A trend toward more frequent cases of severe brachycephaly or plagiocephaly was observed in the control group (n = 5) compared with the OMT group (n = 1; p = 0.09). No adverse effects were reported.
This study did not find any significant effect of OMT on the occurrence of cranial positional deformities. However, recruitment and follow-up difficulties, partly linked to the COVID-19 pandemic, resulted in an underpowered study that does not allow definitive conclusions to be drawn on potential benefits of OMT.