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Abstract
Objective Previous studies have assessed breastfeeding-support programmes. Among these, osteopathic manipulative treatment (OMT) is a frequently used approach, although without strong evidence of efficacy.
Methods A double-blind randomised controlled trial was conducted between July 2013 and March 2016. Breastfed term infants were eligible if one of the following criteria was met: suboptimal breastfeeding behaviour, maternal cracked nipples or maternal pain. The infants were randomly assigned to the intervention or the control group. The intervention consisted of two sessions of early OMT, while in the control group, the manipulations were performed on a doll behind a screen. The primary outcome was the exclusive breastfeeding rate at 1 month, which was assessed in an intention-to-treat analysis. Randomisation was computer generated and only accessible to the osteopath practitioner. The parents, research assistants and paediatricians were masked to group assignment.
Results One hundred twenty-eight mother–infant dyads were randomised, with 64 assigned to each group. In each group, five infants were lost to follow-up. In the intervention group, 31 of 59 (53%) of infants were still exclusively breast fed at 1 month vs 39 of 59 (66%) in the control group, (OR 0.55, 95% CI 0.26 to 1.17; p=0.12). After adjustment for suboptimal breastfeeding behaviour, caesarean section, use of supplements and breast shields, the adjusted OR was 0.44 (95% CI 0.17 to 1.11; p=0.08). No adverse effects were reported in either group.
Conclusion OMT did not improve exclusive breast feeding at 1 month.
Trial registration number NCT01890668.
- alternative medicine
- evidence based medicine
- general paediatrics
- infant feeding
- neonatology
Data availability statement
Data are available upon reasonable request. Deidentified individual participant data (including data dictionaries) will be made available, in addition to study protocols, the statistical analysis plan and the informed consent form. These data will be available immediately following publication, ending in 2021, to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to jeanbaptiste.muller@chu-nantes.fr. Requests for data will require a signed data access agreement.
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Data availability statement
Data are available upon reasonable request. Deidentified individual participant data (including data dictionaries) will be made available, in addition to study protocols, the statistical analysis plan and the informed consent form. These data will be available immediately following publication, ending in 2021, to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to jeanbaptiste.muller@chu-nantes.fr. Requests for data will require a signed data access agreement.
Footnotes
Collaborators NEOSTEO osteopath study group: N Cailleau, F Chaligne, M Charlatte, T Chatel, S Roy-Hamon, M Trebaol, F Vivies.
Contributors MDJ—literature search, study concept and design, acquisition, analysis and interpretation of data, drafting of the manuscript, and writing and statistical analysis. J-BM—acquisition, analysis and interpretation of data, drafting of the manuscript and writing critical revision of the manuscript for important intellectual content, and study supervision. J-CR—study concept and design, acquisition, analysis and interpretation of data, drafting of the manuscript, writing and statistical analysis, critical revision of the manuscript for important intellectual content, and study supervision. CB, NC, FC and the NEOSTEO study group—acquisition, analysis and interpretation of data. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.
Funding This work was supported by the Société Européenne de Recherche en Osthéopathie Périnatale et Pédiatrique (SEROPP), the Fonds pour la Recherche en Ostéopathie (FOREOS) and Formation et Recherche Ostéopathie et Prévention (FROP).
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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