Planning a clinical trial of Flash-heated breast milk to decrease morbidity, impr

描述(申请人提供)：计划一项闪热母乳的功效试验，以降低发病率，促进生长，减少艾滋病毒感染婴儿的艾滋病毒传播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6个月，一旦有安全和有营养的食物就停止。资源贫乏地区的许多艾滋病毒阳性母亲在停止纯母乳喂养后，面临着如何喂养婴儿的两难境地。一方面，母乳比大多数食物营养丰富，含有抗体和其他保护成分，可以保护婴儿免受腹泻和上呼吸道感染等常见疾病的侵袭。然而，混合喂养，即母乳和其他食物同时喂养婴儿时，艾滋病毒传播给婴儿的可能性更高。闪电加热表示的母乳可以杀死艾滋病毒，并保持牛奶的大部分营养和保护品质。此前的研究也表明，这对许多母亲来说是可以接受和可行的。因此，对于艾滋病毒阳性的母亲来说，在这个危险的时期，加热浸泡的母乳可能是一种安全和健康的方式来喂养她的婴儿。然而，我们还不知道与停止喂养任何母乳或提供混合饲料的替代方案相比，这项技术是否显著改善了婴儿的健康。我们建议计划在坦桑尼亚进行一项加热母乳的临床试验，以改善婴儿健康。在我们正在计划的这项研究中，主要目的将是确定，与母亲没有接受这种咨询的婴儿相比，一旦引入其他食物，母亲接受了热处理母乳咨询的婴儿是否不太可能感染艾滋病毒，生长发育更好，患急性呼吸道感染或腹泻的天数更少。我们的次要目标是确定当地顾问是否可以通过走访艾滋病毒阳性母亲的家中，向她们提供健康的婴儿喂养做法的教育和支持，从而提高纯母乳喂养和最佳补充喂养的流行率和平均持续时间。研究的这一部分将检查减少的家访时间表，以确定与以前的婴儿喂养咨询研究相比，更简单、更便宜的方法的成功率。此外，我们将确定这两种干预措施的成本效益，以确定是否应该更大规模地实施。规划期将允许前往坦桑尼亚确定合作安排；最终确定研究设计和样本量；选择研究地点；试图获得资金；数据收集工具的设计、翻译和试点；应用于美国和坦桑尼亚的IRBs；以及计划工作人员培训，以及计划在发展中国家进行多地点临床试验的其他必要任务。 公共卫生相关性：发展中国家艾滋病毒+妇女需要更安全的婴儿喂养选择，因为在6个月后将补充食品与母乳喂养混合会增加艾滋病毒传播，完全停止母乳喂养往往会导致生长不良、疾病，有时甚至死亡。热处理表达的母乳可以杀死病毒，同时保留牛奶的营养和免疫学特性，因此可能是一种比其他选择更健康的方法。我们建议计划进行一项研究，以确定当社区妇女探望母亲，就母乳加热和纯母乳喂养向他们提供咨询时，艾滋病毒+母亲的婴儿是否会感染更少、生长更好、艾滋病毒更少。

DESCRIPTION (provided by applicant): Planning an efficacy trial of Flash-heated breast milk to decrease morbidity, improve growth, and reduce HIV transmission in HIV-exposed infants The World Health Organization recommends that HIV positive mothers in developing countries exclusively breastfeed for 6 months, and then stop once safe and nutritious foods are available. Many HIV- positive mothers in resource poor areas face a dilemma about how to feed their babies after they cease exclusively breastfeeding. On one hand, breast milk is richer in nutrients than most foods and contains antibodies and other protective components that protect the infant from common illnesses like diarrhea and upper respiratory infections. However, the likelihood of HIV transmission to the infant is higher with mixed feeds, i.e. when breast milk and other foods are both fed to the infant. Flash-heating expressed breast milk kills HIV and maintains most of the milk's nutritional and protective qualities. Previous research has also indicated that it can be acceptable and feasible for many mothers. Thus, heating expressed breast milk could be a safe and healthy way for an HIV-positive mother to feed her baby during this risky time. However, we do not yet know if this technique significantly improves the health of infants when compared to the alternatives of cessation of feeding any breast milk or providing mixed feeds. We propose to plan a clinical trial of heated breast milk to improve infant health in Tanzania. In the study we are planning, the primary aim will be to determine if infants whose mothers receive counseling on heat- treating expressed breast milk once other foods have been introduced are less likely to become infected with HIV and experience better growth and fewer days sick with acute respiratory infection or diarrhea, compared to infants whose mothers do not receive this counseling. Our secondary aim is to determine if local counselors can improve the prevalence and mean duration of exclusive breastfeeding and optimal complementary feeding by visiting HIV-positive mothers in their homes to give them education and support with healthful infant feeding practices. This portion of the study will examine a reduced home visit schedule to ascertain the success rate of the simpler, less expensive approach compared to previous studies of infant feeding counseling. Additionally, we will establish the cost- effectiveness of these two interventions, to determine if they should be implemented on a larger scale. The planning period will allow travel to Tanzania to define collaborative arrangements; finalize study design and sample size; choose study sites; attempt to secure funding; the design, translation and piloting of data collection instruments; application to US and Tanzanian IRBs; and plan staff trainings, among other necessary tasks to plan to conduct a multi-site clinical trial in a developing country. PUBLIC HEALTH RELEVANCE: Safer infant feeding options for HIV+ women in developing countries are needed because mixing complementary foods with breastfeeding after 6 months increases HIV transmission and stopping breastfeeding altogether often results in poor growth, illness and sometimes death. Heat- treating expressed breast milk kills the virus while preserving milk's nutritional and immunological properties, and thus could be a healthier method than other choices. We propose to plan a study to determine if babies of HIV+ mothers would have fewer infections, better growth and less HIV when their mothers are visited by women from the community to counsel them about heat treatment of breast milk and exclusive breastfeeding.