Clinical Trial: PROMISE EBF: Safety and Efficacy of Exclusive Breastfeeding Promotion in the Era of HIV in Sub-Saharan Africa

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: PROMISE EBF: Promoting Infant Health and Nutrition in Sub-Saharan Africa: Safety and Efficacy of Exclusive Breastfeeding Promotion in the Era of HIV

Brief Summary:

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

Detailed Summary:

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

The benefits of breastfeeding and the negative effects of artificial feeding in underprivileged environments were clearly brought to the public attention in the 1970s, backed by increasingly strong scientific support. As a result the International Code
Sponsor: Centre For International Health

Current Primary Outcome:

  • Exclusive Breastfeeding Rates in Burkina Faso [ Time Frame: 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 [ Time Frame: at 3 months of age ]
  • Exclusive Breastfeeding Rates in Uganda [ Time Frame: at 3 months of age ]
    The EBF prevalences (24-h recall) at 12 weeks in the intervention and control clusters.
  • Exclusive Breastfeeding Rates in South Africa [ Time Frame: at 3 months of age ]
    The EBF prevalences based on 24-h recall at 12 weeks in the intervention and control clusters.


Original Primary Outcome:

  • exclusive breastfeeding rates at 3 months of age
  • infant morbidity, 2 wks diarrhoea prevalence at 3 months


Current Secondary Outcome:

  • Growth [ Time Frame: (up to 6 months of age) ]
  • Per Protocol Analysis of EBF Rates [ Time Frame: at 3 months of age ]
  • Per Protocol Analysis of Infant Morbidity [ Time Frame: at 3 months of age ]


Original Secondary Outcome:

  • growth (up to 6 months of age)
  • micronutrient status at 6 mo of age
  • per protocol analysis of EBF rates at 3 months of age
  • per protocol analysis of infant morbidity at 3 months


Information By: Centre For International Health

Dates:
Date Received: November 7, 2006
Date Started: November 2006
Date Completion:
Last Updated: February 20, 2015
Last Verified: February 2015