Department of Neonatal Medicine, University Hospital Centre Nantes, Nantes, France.
Clinical Epidemiology, Clinical investigation Center (CIC004), University Hospital Centre Nantes, Nantes, France.
Arch Dis Child Fetal Neonatal Ed. 2021 Nov;106(6):591-595. doi: 10.1136/archdischild-2020-319219. Epub 2021 Mar 31.
Previous studies have assessed breastfeeding-support programmes. Among these, osteopathic manipulative treatment (OMT) is a frequently used approach, although without strong evidence of efficacy.
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.
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.
OMT did not improve exclusive breast feeding at 1 month.
NCT01890668.
既往研究评估了母乳喂养支持方案。在这些方案中，整骨治疗（OMT）是一种常用方法，但疗效证据尚不充分。
本研究于 2013 年 7 月至 2016 年 3 月期间开展了一项双盲随机对照试验。如果满足以下标准之一，则符合纳入标准：母乳喂养行为不佳、母亲乳头皲裂或母亲疼痛。婴儿被随机分配到干预组或对照组。干预组接受 2 次早期 OMT，而在对照组中，治疗师在屏风后对玩偶进行操作。主要结局为 1 个月时的纯母乳喂养率，采用意向治疗分析进行评估。随机化由计算机生成，仅对整骨治疗师开放。父母、研究助理和儿科医生对分组情况设盲。
共 128 对母婴被随机分组，每组 64 对。每组各有 5 例婴儿失访。干预组中，59 例婴儿中有 31 例（53%）在 1 个月时仍为纯母乳喂养，而对照组中 59 例婴儿中有 39 例（66%），（OR 0.55，95%CI 0.26 至 1.17；p=0.12）。调整母乳喂养行为不佳、剖宫产、使用补充剂和乳盾后，调整后的 OR 为 0.44（95%CI 0.17 至 1.11；p=0.08）。两组均未报告不良反应。
OMT 并不能提高 1 个月时的纯母乳喂养率。
NCT01890668。
