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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.

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 (Clinicaltrials.gov: NCT00397150) 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, table 1. 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.

 

The EBF-group

Steering Committee: Thorkild Tylleskär, Philippe Van de Perre, Eva-Charlotte Ekström, Nicolas Meda, James K. Tumwine, Chipepo Kankasa, Debra Jackson
 

Participating countries and investigators: (Country PI first, others in alphabetical order of surname)

Norway: Thorkild Tylleskär, Ingunn MS Engebretsen, Lars Thore Fadnes, Eli Fjeld, Knut Fylkesnes, Jørn Klungsøyr, Anne Nordrehaug-Åstrøm, Øystein Evjen Olsen, Bjarne Robberstad, Halvor Sommerfelt

France: Philippe Van de Perre

Sweden: Eva-Charlotte Ekström

Burkina Faso: Nicolas Meda, Hama Diallo, Thomas Ouedrago, Jeremi Rouamba, Bernadette Traoré Germain Traoré, Emmanuel Zabsonré

Uganda: James K. Tumwine, Caleb Bwengye, Charles Karamagi, Victoria Nankabirwa, Jolly Nankunda, Grace Ndeezi, Margaret Wandera

Zambia: Chipepo Kankasa, Mary Katepa-Bwalya, Chafye Siuluta, Seter Siziya

South Africa: Debra Jackson, Mickey Chopra, Mark Colvin, Tanya Doherty, Ameena E Googa, Lyness Matizirofa, Lungiswa Nkonki, David Sanders, Wanga Zembe