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队列简介:促进母乳喂养干预试验(PROBIT)

Cohort profile: The promotion of breastfeeding intervention trial (PROBIT).

作者信息

Patel Rita, Oken Emily, Bogdanovich Natalia, Matush Lidia, Sevkovskaya Zinaida, Chalmers Beverley, Hodnett Ellen D, Vilchuck Konstantin, Kramer Michael S, Martin Richard M

机构信息

School of Social and Community Medicine, University of Bristol, Bristol, UK, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, USA, The National Research and Applied Medicine Mother and Child Centre, Minsk, Belarus, Belarussian Ministry of Health, Minsk, Belarus, Department of Obstetrics and Gynaecology and Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Ontario, Canada, Departments of Pediatrics & Epidemiology, Biostatistics and Occupational Health, McGill University Faculty of Medicine, Montreal, Canada and MRC Centre for Causal Analyses in Translational Epidemiology (CAiTE), School of Social and Community Medicine, University of Bristol, Bristol, UK

School of Social and Community Medicine, University of Bristol, Bristol, UK, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, USA, The National Research and Applied Medicine Mother and Child Centre, Minsk, Belarus, Belarussian Ministry of Health, Minsk, Belarus, Department of Obstetrics and Gynaecology and Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Ontario, Canada, Departments of Pediatrics & Epidemiology, Biostatistics and Occupational Health, McGill University Faculty of Medicine, Montreal, Canada and MRC Centre for Causal Analyses in Translational Epidemiology (CAiTE), School of Social and Community Medicine, University of Bristol, Bristol, UK.

出版信息

Int J Epidemiol. 2014 Jun;43(3):679-90. doi: 10.1093/ije/dyt003. Epub 2013 Mar 7.

Abstract

The PROmotion of Breastfeeding Intervention Trial (PROBIT) is a multicentre, cluster-randomized controlled trial conducted in the Republic of Belarus, in which the experimental intervention was the promotion of increased breastfeeding duration and exclusivity, modelled on the Baby-friendly hospital initiative. Between June 1996 and December 1997, 17,046 mother-infant pairs were recruited during their postpartum hospital stay from 31 maternity hospitals, of which 16 hospitals and their affiliated polyclinics had been randomly assigned to the arm of PROBIT investigating the promotion of breastfeeding and 15 had been assigned to the control arm, in which breastfeeding practices and policies in effect at the time of randomization was continued. Of the mother-infant pairs originally recruited for the study, 16,492 (96.7%) were followed at regular intervals until the infants were 12 months of age (PROBIT I) for the outcomes of breastfeeding duration and exclusivity; gastrointestinal and respiratory infections; and atopic eczema. Subsequently, 13,889 (81.5%) of the children from these mother-infant pairs were followed-up at age 6.5 years (PROBIT II) for anthropometry, blood pressure (BP), behaviour, dental health, cognitive function, asthma and atopy outcomes, and 13,879 (81.4%) children were followed to the age of 11.5 years (PROBIT III) for anthropometry, body composition, BP, and the measurement of fasted glucose, insulin, adiponectin, insulin-like growth factor-I, and apolipoproteins. The trial registration number for Current Controlled Trials is ISRCTN37687716 and that for ClinicalTrials.gov is NCT01561612. Proposals for collaboration are welcome, and enquires about PROBIT should be made to an executive group of the study steering committee (M.S.K., R.M.M., and E.O.). More information, including information about how to access the trial data, data collection documents, and bibliography, is available at the trial website (http://www.bristol.ac.uk/social-community-medicine/projects/probit/).

摘要

母乳喂养促进干预试验(PROBIT)是在白俄罗斯共和国进行的一项多中心、整群随机对照试验。该试验中的实验性干预措施是参照爱婴医院倡议,促进延长母乳喂养时间并实现纯母乳喂养。1996年6月至1997年12月期间,从31家妇产医院招募了17046对母婴,她们在产后住院期间被纳入研究。其中,16家医院及其附属门诊被随机分配到PROBIT研究中促进母乳喂养的实验组,15家被分配到对照组,对照组继续沿用随机分组时有效的母乳喂养做法和政策。在最初招募参加该研究的母婴对中,16492对(96.7%)被定期随访,直至婴儿12个月大(PROBIT I),以获取母乳喂养时间和纯母乳喂养情况、胃肠道和呼吸道感染以及特应性皮炎等结果。随后,这些母婴对中的13889名儿童(81.5%)在6.5岁时接受了随访(PROBIT II),以获取人体测量数据、血压(BP)、行为、牙齿健康、认知功能、哮喘和特应性结果;13879名儿童(81.4%)在11.5岁时接受了随访(PROBIT III),以获取人体测量数据、身体成分、血压以及空腹血糖、胰岛素、脂联素、胰岛素样生长因子-I和载脂蛋白的测量结果。当前对照试验的试验注册号为ISRCTN37687716,ClinicalTrials.gov的注册号为NCT01561612。欢迎合作提议,有关PROBIT的咨询应向研究指导委员会的执行小组(M.S.K.、R.M.M.和E.O.)提出。更多信息,包括如何获取试验数据、数据收集文件和参考文献等信息,可在试验网站(http://www.bristol.ac.uk/social-community-medicine/projects/probit/)上获取。

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