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促进母乳喂养干预试验(PROBIT):白俄罗斯共和国的一项随机试验。

Promotion of Breastfeeding Intervention Trial (PROBIT): a randomized trial in the Republic of Belarus.

作者信息

Kramer M S, Chalmers B, Hodnett E D, Sevkovskaya Z, Dzikovich I, Shapiro S, Collet J P, Vanilovich I, Mezen I, Ducruet T, Shishko G, Zubovich V, Mknuik D, Gluchanina E, Dombrovskiy V, Ustinovitch A, Kot T, Bogdanovich N, Ovchinikova L, Helsing E

机构信息

Department of Pediatrics, McGill University Faculty of Medicine, Montreal, Quebec, Canada.

出版信息

JAMA. 2001;285(4):413-20. doi: 10.1001/jama.285.4.413.

DOI:10.1001/jama.285.4.413
PMID:11242425
Abstract

CONTEXT

Current evidence that breastfeeding is beneficial for infant and child health is based exclusively on observational studies. Potential sources of bias in such studies have led to doubts about the magnitude of these health benefits in industrialized countries.

OBJECTIVE

To assess the effects of breastfeeding promotion on breastfeeding duration and exclusivity and gastrointestinal and respiratory infection and atopic eczema among infants.

DESIGN

The Promotion of Breastfeeding Intervention Trial (PROBIT), a cluster-randomized trial conducted June 1996-December 1997 with a 1-year follow-up.

SETTING

Thirty-one maternity hospitals and polyclinics in the Republic of Belarus.

PARTICIPANTS

A total of 17 046 mother-infant pairs consisting of full-term singleton infants weighing at least 2500 g and their healthy mothers who intended to breastfeed, 16491 (96.7%) of which completed the entire 12 months of follow-up.

INTERVENTIONS

Sites were randomly assigned to receive an experimental intervention (n = 16) modeled on the Baby-Friendly Hospital Initiative of the World Health Organization and United Nations Children's Fund, which emphasizes health care worker assistance with initiating and maintaining breastfeeding and lactation and postnatal breastfeeding support, or a control intervention (n = 15) of continuing usual infant feeding practices and policies.

MAIN OUTCOME MEASURES

Duration of any breastfeeding, prevalence of predominant and exclusive breastfeeding at 3 and 6 months of life and occurrence of 1 or more episodes of gastrointestinal tract infection, 2 or more episodes of respiratory tract infection, and atopic eczema during the first 12 months of life, compared between the intervention and control groups.

RESULTS

Infants from the intervention sites were significantly more likely than control infants to be breastfed to any degree at 12 months (19.7% vs 11.4%; adjusted odds ratio [OR], 0.47; 95% confidence interval [CI], 0.32-0.69), were more likely to be exclusively breastfed at 3 months (43.3% vs 6.4%; P<.001) and at 6 months (7.9% vs 0.6%; P =.01), and had a significant reduction in the risk of 1 or more gastrointestinal tract infections (9.1% vs 13.2%; adjusted OR, 0.60; 95% CI, 0.40-0.91) and of atopic eczema (3.3% vs 6.3%; adjusted OR, 0.54; 95% CI, 0.31-0.95), but no significant reduction in respiratory tract infection (intervention group, 39.2%; control group, 39.4%; adjusted OR, 0.87; 95% CI, 0.59-1.28).

CONCLUSIONS

Our experimental intervention increased the duration and degree (exclusivity) of breastfeeding and decreased the risk of gastrointestinal tract infection and atopic eczema in the first year of life. These results provide a solid scientific underpinning for future interventions to promote breastfeeding.

摘要

背景

目前关于母乳喂养对婴幼儿健康有益的证据完全基于观察性研究。此类研究中潜在的偏倚来源引发了人们对工业化国家中这些健康益处程度的质疑。

目的

评估促进母乳喂养对婴儿母乳喂养持续时间、纯母乳喂养情况以及胃肠道和呼吸道感染及特应性皮炎的影响。

设计

母乳喂养促进干预试验(PROBIT),这是一项于1996年6月至1997年12月进行的整群随机试验,并进行了为期1年的随访。

地点

白俄罗斯共和国的31家妇产医院和综合诊所。

参与者

共有17046对母婴,其中足月单胎婴儿体重至少2500克,其健康母亲打算进行母乳喂养,其中16491对(96.7%)完成了整个12个月的随访。

干预措施

各地点被随机分配接受一种实验性干预(n = 16),该干预以世界卫生组织和联合国儿童基金会的爱婴医院倡议为蓝本,强调医护人员在启动和维持母乳喂养及泌乳方面的协助以及产后母乳喂养支持,或者接受一种对照干预(n = 15),即继续常规的婴儿喂养做法和政策。

主要观察指标

比较干预组和对照组在12个月时任何程度母乳喂养的持续时间、3个月和6个月时纯母乳喂养和完全母乳喂养的患病率,以及在生命的前12个月内发生1次或更多次胃肠道感染、2次或更多次呼吸道感染和特应性皮炎的情况。

结果

干预组的婴儿在12个月时进行任何程度母乳喂养的可能性显著高于对照组婴儿(19.7%对11.4%;调整后的优势比[OR]为0.47;95%置信区间[CI]为0.32 - 0.69),在3个月时纯母乳喂养的可能性更高(43.3%对6.4%;P <.001),在6个月时也是如此(7.9%对0.6%;P = 0.01),并且1次或更多次胃肠道感染的风险显著降低(9.1%对13.2%;调整后的OR为0.60;95% CI为0.40 - 0.91),特应性皮炎的风险也显著降低(3.3%对6.3%;调整后的OR为0.54;95% CI为0.31 - 0.95),但呼吸道感染风险没有显著降低(干预组为39.2%;对照组为39.4%;调整后的OR为0.87;95% CI为0.59 - 1.28)。

结论

我们的实验性干预增加了母乳喂养的持续时间和程度(纯母乳喂养),并降低了生命第一年胃肠道感染和特应性皮炎的风险。这些结果为未来促进母乳喂养的干预措施提供了坚实的科学依据。

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