Clinical Epidemiology and Public Health Research Unit, Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, Italy.
Neonatal Intensive Care Unit, Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, Italy.
Int Breastfeed J. 2020 Apr 5;15(1):21. doi: 10.1186/s13006-020-00261-4.
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.
生物养育是一种支持母乳喂养的神经行为方法,鼓励母亲以放松、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),使婴儿更容易衔乳,从而促进纯母乳喂养的开始。然而,它在现实生活中的效果尚未得到充分研究。本随机对照试验的目的是评估与医院常规做法相比,生物养育在减少产妇乳房问题的发生率和在出院时、1 周后和 4 个月时纯母乳喂养的流行率方面的有效性。
这是一项在意大利里雅斯特的三级妇产医院(IRCCS Burlo Garofolo)进行的开放性随机平行对照试验,于 2018 年 3 月至 12 月进行。在妊娠期间招募了 208 名计划在该医院分娩并表示有母乳喂养意愿的女性,将她们随机分为两组,分别接受生物养育方法或基于世界卫生组织/联合国儿童基金会 20 小时课程的医院常规护理方案,以支持母乳喂养。主要研究结局是住院期间乳房问题的发生率,定义为以下一个或多个结果的存在:乳头疼痛、乳头皲裂、乳房肿胀和乳腺炎。主要分析是按意向治疗进行的。随访持续 4 个月。
在 208 名女性中,有 188 名(90.3%)纳入了分析,其中 90 名被分配到生物养育组,98 名被分配到常规护理组。出院时,生物养育组显著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),包括乳头皲裂(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 个月时,纯母乳喂养的比例没有统计学差异。没有观察到不良事件。
在三级医院的现实情况下应用生物养育方法,可有效预防乳房问题。
Clinicaltrials.gov NCT03503500。首次提交日期:2018 年 3 月 28 日。