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

描述（由申请人提供）：计划对接触艾滋病毒的婴儿进行快速加热母乳降低发病率、促进生长和减少艾滋病毒传播的功效试验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，然后在获得安全和营养食品后停止。在资源贫乏地区，许多艾滋病毒阳性的母亲在停止纯母乳喂养后面临着如何喂养婴儿的困境。一方面，母乳比大多数食物营养更丰富，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害。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。快速加热的母乳可以杀死艾滋病毒，并保持母乳的大部分营养和保护特性。先前的研究也表明，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，加热母乳可能是一种安全健康的喂养方式。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法相比，这种技术是否能显著改善婴儿的健康。我们建议计划一项加热母乳的临床试验，以改善坦桑尼亚的婴儿健康。在我们正在计划的研究中，主要目的是确定，与母亲没有接受这种咨询的婴儿相比，母亲接受热处理母乳咨询的婴儿在引入其他食物后，是否更不容易感染艾滋病毒，发育更好，患急性呼吸道感染或腹泻的天数更少。我们的第二个目标是确定当地顾问是否可以通过访问艾滋病毒阳性母亲的家中，向她们提供健康婴儿喂养方法的教育和支持，从而提高纯母乳喂养和最佳补充喂养的普及率和平均持续时间。研究的这一部分将检查减少的家访时间表，以确定与之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，以确定它们是否应该在更大的范围内实施。规划期间将允许前往坦桑尼亚确定合作安排；确定研究设计和样本量；选择研究地点；努力获得资金；数据采集仪器的设计、翻译和调试；向美国和坦桑尼亚国内审查局申请；计划员工培训，以及计划在发展中国家开展多地点临床试验的其他必要任务。

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.