PROMISE EBF: Promoting Infant Health and Nutrition in Sub-Saharan Africa: Safety and Efficacy of Exclusive Breastfeeding Promotion in the Era of HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,579
- 试验地点
- 4
- 主要终点
- Exclusive Breastfeeding Rates in Uganda
研究概览
简要总结
The objective of the project is to develop and test an intervention to promote exclusive breastfeeding (EBF), to assess its impact on infant health in African contexts where a high prevalence of HIV is a barrier, and to strengthen the evidence base regarding the optimal duration for EBF.
Promotion of EBF is the most effective child health intervention currently feasible for implementation at the population level in low-income countries. It can lower infant mortality by 13%, and by an additional 2% were it not for the fact that breastfeeding transmits HIV. Only recently proven to be possible in hot and even dry climates, EBF without even offering water is still little appreciated by mothers or supported by health workers. EBF rates are especially low in Africa but the potential for rapid implementation may be high. A few studies elsewhere suggest that peer counselling can often achieve dramatic increases. Thus the investigators will run the first randomised trial to develop and test models for applying this approach in four African countries and to quantify health benefits, cost-effectiveness, and implications for the health care system.
While experts realize that the HIV threat ought not to present much of a biological constraint to promoting EBF, in heavily affected countries it does represent a cultural constraint. Overcoming this will require the development of a safe and effective means of promoting EBF that is HIV-sensitive by taking into account the need to minimise postnatal HIV transmission.
Another scientific constraint to the promotion of exclusive breastfeeding for six months, as recommended by the World Health Organization (WHO), is uncertainty about its impact on the micronutrient status of infants. In a substudy, the investigators will carefully follow markers of infant micronutrient status to see how they vary by feeding pattern, including EBF, for a longer period than has been examined previously.
详细描述
Rationale
The single most effective way of saving the lives of millions of young children in developing countries would be the promotion of exclusive breastfeeding (EBF). Over a period of 10 years it could save the lives of an estimated 15 million children.
"Infants aged 0-5 months who are not breastfed have seven-fold and five-fold increased risks of death from diarrhoea and pneumonia respectively, compared with infants who are exclusively breastfed. At the same age, non-exclusive rather than exclusive breastfeeding results in more than two-fold increased risks of dying from diarrhoea and pneumonia." Lancet 2003; 361: 2226-34
This assertion, and related comments and findings, set out by the Bellagio Child Survival Group in a recent article in the Lancet summarising findings from international research of how best to reduce infant mortality in developing countries, is made despite our limited knowledge of how best to promote EBF. This proposal addresses the urgent need to tackle this limitation. How best to promote EBF needs attention because it will be necessary to secure high rates of support for EBF from young mothers, and we do not currently know the best way to bring this about, particularly in the cultural context of Africa. Unless we can find more effective strategies to combat poor feeding practices in both health facility and community settings, the child mortality rate will continue to be high.
Breastfeeding
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Lives in a selected cluster
- •Is >= 6 months pregnant
- •Has no plans to move outside of the cluster within 1 year
排除标准
- •Reduced ability to collaborate for psychological/mental reasons
- •Severely ill
- •Has given birth more than 7 days ago
- •Has given birth less than 7 days ago and it was a multiple birth; or the child has a severe malformation; or death of the mother or the baby.
研究组 & 干预措施
Intervention
Peer-support for exclusive breastfeeding
干预措施: Peer-support for exclusive breastfeeding (Behavioral)
No intervention
No intervention
结局指标
主要结局
Exclusive Breastfeeding Rates in Uganda
时间窗: at 3 months of age
The EBF prevalences (24-h recall) at 12 weeks in the intervention and control clusters.
Exclusive Breastfeeding Rates in Burkina Faso
时间窗: at 3 months of age
The EBF prevalences (24-h recall) at 12 weeks in the intervention and control clusters.
Infant Morbidity, 2 Week Diarrhoea Prevalence
时间窗: at 3 months of age
Exclusive Breastfeeding Rates in South Africa
时间窗: at 3 months of age
The EBF prevalences based on 24-h recall at 12 weeks in the intervention and control clusters.
次要结局
- Per Protocol Analysis of Infant Morbidity(at 3 months of age)
- Per Protocol Analysis of EBF Rates(at 3 months of age)
- Growth((up to 6 months of age))
研究者
Thorkild Tylleskar
Professor
Centre For International Health