Biological nurturing is a neurobehavioral approach to breastfeeding support that encourages women to breastfed in a relaxed, laidback position. This approach has the potential to reduce breast problems (e.g., sore nipples), making good latch easier and thus facilitating the initiation of exclusive breastfeeding. However, its effects have not been adequately investigated in a real-life situation. The aim of this randomized controlled trial was to assess the effectiveness of biological nurturing, compared to usual hospital practices, on the frequency of breast problems and on the prevalence of exclusive breastfeeding at discharge from the maternity ward, after 1 week, and at one and 4 months. Open randomized parallel controlled trial carried out in a third level maternity ward (IRCCS Burlo Garofolo, Trieste, Italy) between March and December 2018. Two-hundred eight women who planned to give birth at the hospital and who expressed the intention to breastfeed were enrolled during pregnancy and randomized to receive breastfeeding support following either the biological nurturing approach or the usual care protocol based on the WHO/UNICEF 20-h course, in use at the hospital. The primary study outcome was the incidence of breast problems during hospital stay, defined as the presence of one or more of the following outcomes, collected separately: sore nipples, cracked nipples, engorgement and mastitis. The primary analysis was performed by intention to treat. The follow up lasted 4 months. One hundred eighty eight out of 208 women (90.3%) were included in the analysis, 90 allocated to the biological nurturing group and 98 to the usual care group. At discharge from the maternity ward, biological nurturing significantly reduced the risk of breast problems (Relative risk [RR] 0.56, 95% Confidence Interval [CI] 0.40, 0.79), including cracked (RR 0.42, 95% CI 0.24, 0.74) and sore nipples (RR 0.59, 95% CI 0.40, 0.88). No statistically significant difference was observed for exclusive breastfeeding at discharge and up to 4 months. No adverse events occurred. The biological nurturing approach applied in the real-life situation of a third level hospital was effective in preventing breast problems. Clinicaltrials.gov NCT03503500. Date of First Submission: 28 March 2018.

中文翻译：

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生物喂养对早期母乳喂养问题的有效性：一项随机对照试验。


生物喂养是一种支持母乳喂养的神经行为方法，鼓励女性以轻松、悠闲的姿势进行母乳喂养。这种方法有可能减少乳房问题（例如乳头疼痛），使衔乳更容易，从而促进纯母乳喂养的开始。然而，其影响尚未在现实​​生活中得到充分研究。这项随机对照试验的目的是评估与通常的医院做法相比，生物喂养对乳房问题发生频率以及产房出院时、1 周后、1 周和 1 周时纯母乳喂养流行率的有效性。 4个月。 2018 年 3 月至 12 月在三级产科病房（IRCCS Burlo Garofolo，里雅斯特，意大利）进行的开放式随机平行对照试验。纳入了 208 名计划在医院分娩并表示打算母乳喂养的妇女怀孕期间，并随机接受母乳喂养支持，遵循生物培育方法或基于医院使用的世界卫生组织/联合国儿童基金会 20 小时课程的常规护理方案。主要研究结果是住院期间乳房问题的发生率，定义为存在以下一种或多种结果，单独收集：乳头疼痛、乳头破裂、肿胀和乳腺炎。主要分析是按意向治疗进行的。随访持续4个月。 208 名女性中的 188 名 (90.3%) 被纳入分析，其中 90 名分配到生物养育组，98 名分配到常规护理组。从产房出院时，生物喂养显着降低了乳房问题的风险（相对风险 [RR] 0.56，95% 置信区间 [CI] 0.40, 0.79），包括乳头破裂（RR 0.42，95% CI 0.24，0.74）和乳头疼痛（RR 0.59，95% CI 0.40，0.88）。出院时和 4 个月内的纯母乳喂养没有观察到统计学上的显着差异。没有发生不良事件。三级医院实际应用的生物培育方法，有效预防乳腺问题。临床试验.gov NCT03503500。首次提交日期：2018 年 3 月 28 日。