PROMISE EBF: Safety and efficacy of exclusive breastfeeding promotion in the era of HIV

Exclusive breastfeeding (EBF) for the first six months is an effective child survival strategy.

Full project title: Promoting infant health and nutrition in Sub-Saharan Africa: Safety and efficacy of exclusive breastfeeding promotion in the era of HIV (PROMISE EBF)
Coordinator: Thorkild Tylleskär
Period: 2005-2011
Funding:
European Union 6th Framework Programme (FP6)
Research Council of Norway
Sida/Sarec, Sweden
Medical Research Council, South Africa

Relevant links: Clinicaltrials.gov: NCT00397150 / EU Project ID: 3660 /

Description: Promotion of EBF is the most effective child health intervention currently feasible for implementation at 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. Proven to be possible in hot and even dry climates, EBF without even offering water is seldom practiced by mothers worldwide. EBF rates are especially low in Africa, but the potential for rapid implementation may be high. A few studies elsewhere suggest that peer counselling has achieved dramatic increases in EBF prevalence. Thus we have run the first randomised trial to develop and test models for applying this approach in four African countries Burkina Faso, Uganda, Zambia and South Africa and to quantify health benefits, cost-effectiveness and implications for the health care system. The PROMISE EBF-trial assessed the effect of individual counselling for exclusive breastfeeding by peer-counsellors. We report the preliminary results of the outcomes: exclusive breastfeeding rates and the diarrhoea prevalence at 12 and 24 weeks of age.

Methods: PROMISE EBF was conducted as a multicentre community cluster-randomised trial in four African countries, Burkina Faso, Uganda, Zambia and South Africa. In each country 24-34 clusters were randomised (12-17 intervention and 12-17 control, >800 mother-infant pairs/country). The eligibility criteria: pregnant women residing in and intending to continue living in the study areas who consented to study participation. Infants with severe illness preventing breastfeeding were excluded. A minimum of five peer visits, from an antenatal visit were scheduled for mothers in intervention clusters. Control clusters received standard care, mainly health promotion through antenatal care. Data collection (2006-2008) was by independent interviewers via a series of five home visits to determine feeding patterns, infant morbidity, anthropometry and survival. All analyses adjusted for cluster effects.

Results: Exclusive breastfeeding rates at 12 and 24 weeks of age were about twice as high in the intervention arm in Burkina Faso, Uganda and South Africa. In Zambia the rates were reportedly high. Preliminary results in the intervention and control groups at 12 weeks were: 84% and 36% in Burkina Faso (Prevalence Ratio (PR) 2.34; 95%CI 1.31-4.16), 87% and 49% in Uganda (PR 1.78; 95%CI 1.59-1.98), and 11% and 7% in South Africa (PR 1.69; 95%CI 1.08-2.65), respectively. A similar pattern is also seen at 24 weeks. There was no consistent difference in diarrhoea prevalence between the two arms.

Conclusion: Preliminary results suggest a positive effect of peer-counselling on exclusive breastfeeding rates, with large country differences observed.