Feasibility and Pilot Efficacy of Flash-heated Breastmilk to Reduce Pediatric HIV

描述（由申请人提供）：世界卫生组织（WHO）建议，除非母乳替代品是可接受的、可行的、负担得起的、可持续的和安全的，否则发展中国家的艾滋病毒阳性母亲应在前6个月完全母乳喂养。产后和断奶后，当营养充足和安全的饮食是可用的。断奶期对这些婴儿来说可能是高风险的，因为缺乏充分的替代饲料，导致营养不良，并因母乳的免疫保护丧失而易患腹泻和呼吸道疾病。此外，如果母亲在断奶期间母乳喂养，由于这段时间母乳病毒载量较高，艾滋病毒传播的风险会增加。在断奶期间和之后，迫切需要适当的喂养替代品。虽然被世界卫生组织列为母乳喂养的修改，热处理尚未得到充分探讨。我们的数据表明，闪热（FH），一种简单的家庭巴氏杀菌方法，能够灭活感染母乳中的HIV，同时保持大多数维生素和免疫球蛋白。这表明FHed母乳可以作为断奶期间和断奶后的婴儿喂养选择，以降低引入辅食的风险。本研究将探讨使用强化的同伴为基础的婴儿喂养咨询，以提高纯母乳喂养（EBF）的持续时间和FHing母乳的可行性。计划母乳喂养的艾滋病毒感染母亲将在坦桑尼亚的医院进行产前招募，并向EBF提供加强咨询。经过培训的社区卫生工作者将每周进行家访，以支持母亲并收集婴儿喂养和乳房健康数据。在引入辅食之前，将讨论FH作为过渡期间和过渡之后的一种选择。选择FH的母亲将获得家庭支持，并随访长达3个月。从断奶。FHing母乳的可行性和初步疗效研究将用于指导全面的疗效试验。具体目标包括：1）确定增强家庭支持对EBF持续时间的影响。鉴于坦桑尼亚临床人员短缺，CHW可以为EBF提供更长时间的支持。2)确定母亲在家中使用FH方法和遵守方案的情况。通过加强培训和支持，母亲可以选择FH牛奶，这表明它对婴儿喂养是可行的。3)确定FHed母乳在田间环境中的安全性。将采集乳汁样本并进行HIV灭活和细菌计数分析，以确保方法安全性。4)开展FH疗效试验，以改善婴儿健康结局。诊所助理将在每月两次的家访中监测婴儿的生长和发病率。可行性数据对于正确规划有效性试验是必要的，反过来也是必要的，以便咨询师能够更好地告知母亲未来不同喂养选择的风险和益处。项目相关性 世界卫生组织建议发展中国家的艾滋病毒阳性母亲完全母乳喂养六个月，然后一旦获得安全和营养的食物就停止，但这段断奶期对婴儿来说可能是一个危险的时期，因为缺乏完全的营养，受污染的食物生病的机会，甚至如果母亲母乳喂养，感染艾滋病毒的可能性增加。加热挤出的母乳可以杀死艾滋病毒并保持牛奶的保护性，因此在这个危险时期，母亲喂养婴儿可能是一种安全健康的方式。在这项研究中，我们将看看来自社区的妇女谁访问艾滋病毒阳性母亲在他们的家中可以增加纯母乳喂养的平均持续时间，如果它是可行的母亲表达和加热后，他们介绍其他食物的牛奶。

DESCRIPTION (provided by applicant): The World Health Organization (WHO) recommends that unless breastmilk substitutes are acceptable, feasible, affordable, sustainable, and safe, HIV positive mothers in developing countries should exclusively breastfeed for the first 6 mos. Postpartum and wean thereafter when a nutritionally adequate and safe diet is available. The weaning period can be high risk for such infants due to lack of fully adequate replacement feeds resulting in malnutrition and susceptibility to diarrheal and respiratory illness from loss of breastmilk's immune protection. In addition, risk of HIV transmission is increased if a mother breastfeeds during weaning due to higher breastmilk viral load during this time. Appropriate feeding alternatives during and after weaning are urgently needed. Although listed by WHO as a breastfeeding modification, heat treatment has not been fully explored. Our data demonstrate that Flash-heat (FH), a simple home pasteurization method, is capable of inactivating HIV in infected breastmilk while maintaining most vitamins and immunoglobulins. This suggests FHed breastmilk could be an infant feeding option during and after weaning to decrease risks of introducing complementary foods. This study will investigate use of enhanced peer-based infant feeding counseling to improve exclusive breastfeeding (EBF) durations and the feasibility of FHing breastmilk. HIV-infected mothers who plan to breastfeed will be recruited antenatally at hospitals in Tanzania and provided enhanced counseling to EBF. Trained community health workers (CHWs) will make weekly home visits to support mothers and collect infant feeding and breast health data. Prior to introduction of complementary foods, FH will be discussed as an option for during and after transition. Mothers who choose FH will be provided home-based support and followed for up to 3 mos. from weaning. This feasibility and pilot efficacy study of FHing breastmilk will be used to guide a full-scale efficacy trial. Specific aims include to: 1) Determine the impact of enhanced home-based support on EBF duration. Given clinical staffing shortages in Tanzania, CHWs could provide support needed to EBF longer. 2) Determine uptake of the FH method and protocol adherence by mothers in their homes. With enhanced training and support, mothers may choose to FH milk, suggesting it could be practical for infant feeding. 3) Determine safety of FHed breastmilk in a field setting. Milk samples will be collected and assayed for HIV inactivation and bacterial counts to ensure method safety. 4) To pilot an efficacy trial of FH to improve infant health outcomes. Clinic assistants will monitor infant growth and morbidity during home visits twice monthly. Feasibility data are necessary to properly plan an efficacy trial, in turn necessary so that counselors can better inform mothers of risks and benefits of different feeding options in the future. Project Relevance The World Health Organization recommends that HIV positive mothers in developing countries exclusively breastfeed for six months then stop once safe and nutritious foods are available, but this weaning period can be a risky time for the baby because of lack of complete nutrition, the chance of getting sick from contaminated foods and even an increased possibility of getting HIV if the mother breastfeeds. Heating expressed breastmilk can kill HIV and keep milk's protective qualities, so it could be a safe and healthy way for a mother to feed her baby during this risky time. In this study, we will see if women from the community who visit HIV positive mothers in their homes could increase the mean duration of exclusive breastfeeding and if it is feasible for mothers to express and heat their milk after they introduce other foods.