Early osteopathic manipulative treatment to prevent cranial positional deformities: A randomized controlled trial.

IF 1.3 4区 医学 Q3 PEDIATRICS Archives De Pediatrie Pub Date : 2025-01-27 DOI:10.1016/j.arcped.2024.11.003
Catherine Genelot, Valérie Macioce, Héléna Huguet, Inge Harrewijn, Gilles Cambonie, David Dessauge, Thibault Mura, Lionel Moulis, Guillaume Captier
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Abstract

Background: Cranial positional deformities occur frequently in the first months of life.

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

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来源期刊
Archives De Pediatrie
Archives De Pediatrie 医学-小儿科
CiteScore
2.80
自引率
5.60%
发文量
106
审稿时长
24.1 weeks
期刊介绍: Archives de Pédiatrie publishes in English original Research papers, Review articles, Short communications, Practice guidelines, Editorials and Letters in all fields relevant to pediatrics. Eight issues of Archives de Pédiatrie are released annually, as well as supplementary and special editions to complete these regular issues. All manuscripts submitted to the journal are subjected to peer review by international experts, and must: Be written in excellent English, clear and easy to understand, precise and concise; Bring new, interesting, valid information - and improve clinical care or guide future research; Be solely the work of the author(s) stated; Not have been previously published elsewhere and not be under consideration by another journal; Be in accordance with the journal''s Guide for Authors'' instructions: manuscripts that fail to comply with these rules may be returned to the authors without being reviewed. Under no circumstances does the journal guarantee publication before the editorial board makes its final decision. Archives de Pédiatrie is the official publication of the French Society of Pediatrics.
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