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（世卫组织）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婴儿出生后的前6个月完全母乳喂养。产后和断奶后，当有足够的营养和安全的饮食。由于缺乏充分的替代饲料，导致营养不良，并且由于失去母乳的免疫保护而容易腹泻和呼吸道疾病，因此断奶期对这些婴儿来说可能是高风险的。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也会增加。在断奶期间和断奶后，迫切需要适当的喂养选择。尽管世界卫生组织将热处理列为母乳喂养的一种改良方法，但尚未对其进行充分探索。我们的数据表明，闪热（FH），一种简单的家庭巴氏灭菌方法，能够在保持大多数维生素和免疫球蛋白的同时灭活受感染母乳中的HIV。这表明FHed母乳可以作为婴儿断奶期间和断奶后的一种喂养选择，以降低引入辅食的风险。本研究将探讨使用增强的基于同伴的婴儿喂养咨询来改善纯母乳喂养（EBF）的持续时间和FHing母乳的可行性。坦桑尼亚的医院将在产前招募计划母乳喂养的感染艾滋病毒的母亲，并向EBF提供更多咨询。训练有素的社区卫生工作者将每周进行家访，为母亲提供支持，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作为过渡期间和之后的一种选择。选择计划生育的母亲将获得家庭支持，并接受长达3个月的随访。从断奶。FHing母乳的可行性和中试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。鉴于坦桑尼亚的临床人员短缺，卫生工作者可以为EBF提供更长时间所需的支持。2)确定母亲在家中对家庭生育方法的接受情况和对方案的遵守情况。在加强培训和支持的情况下，母亲可能会选择FH奶，这表明它对婴儿喂养是可行的。3)在野外环境中确定FHed母乳的安全性。将收集牛奶样本并进行艾滋病毒灭活和细菌计数分析，以确保方法的安全性。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家访期间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，反过来又有必要，以便咨询师能够更好地告知母亲未来不同喂养方案的风险和益处。项目相关

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.