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

描述(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该在前6个月完全母乳喂养。产后和之后，当营养充足和安全的饮食可用时断奶。由于缺乏充分的替代饲料，导致营养不良，并因失去母乳的免疫保护而易患腹泻和呼吸道疾病，断奶期间对这类婴儿可能是高风险的。此外，如果母亲在断奶期间母乳喂养，则艾滋病毒传播的风险会增加，因为在此期间母乳病毒载量较高。在断奶期间和断奶后，迫切需要适当的饲喂替代品。尽管世卫组织将其列为母乳喂养的改进措施，但热处理尚未得到充分探索。我们的数据表明，闪热(FH)，一种简单的家庭巴氏杀菌方法，能够灭活受感染母乳中的艾滋病毒，同时保持大多数维生素和免疫球蛋白。这表明FHed母乳可以在断奶期间和之后作为婴儿喂养的一种选择，以降低引入补充食物的风险。本研究将探讨加强以同伴为基础的婴儿喂养辅导，以改善纯母乳喂养(EBF)的持续时间，以及FHING母乳喂养的可行性。计划母乳喂养的艾滋病毒感染母亲将在坦桑尼亚的医院接受产前招募，并为EBF提供加强咨询。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。在引入补充食品之前，FH将作为过渡期间和之后的一种选择进行讨论。选择FH的母亲将得到以家庭为基础的支持，并被跟踪长达3个月。从断奶开始。这项FHING母乳的可行性和中试疗效研究将用于指导一项全面的疗效试验。具体目标包括：1)确定增强的家庭支持对EBF持续时间的影响。鉴于坦桑尼亚的临床人员短缺，社区卫生组织可以提供更长时间的EBF所需的支持。2)确定母亲在家中对FH方法的接受情况和遵守方案。在加强培训和支持的情况下，母亲们可能会选择FH母乳，这表明这可能对婴儿喂养是可行的。3)现场检测FHed母乳的安全性。牛奶样本将被收集并进行艾滋病毒灭活和细菌计数检测，以确保方法安全。4)试行FH的疗效试验以改善婴儿的健康结局。诊所助理将在每月两次的家访期间监测婴儿的生长发育和发病率。可行性数据对于正确计划有效性试验是必要的，反过来也是必要的，这样咨询师就可以更好地告知母亲未来不同喂养选择的风险和好处。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纯母乳喂养六个月，一旦有安全和有营养的食物就停止喂养，但这段断奶时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，因受污染的食物而生病的机会，甚至如果母亲母乳喂养，感染艾滋病毒的可能性增加。加热浸泡的母乳可以杀死艾滋病毒，并保持牛奶的保护性质，所以对于母亲来说，在这个危险的时期喂养婴儿可能是一种安全和健康的方式。在这项研究中，我们将研究社区妇女在家中拜访艾滋病毒阳性母亲是否可以增加纯母乳喂养的平均持续时间，以及母亲在引入其他食物后表达和加热她们的母乳是否可行。

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.