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N/A N=2,579 Randomized Prevention

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

Diarrhea

Enrolled (actual)
2,579
Serious AEs
2.1%
Results posted
Feb 2015
Primary outcome: Primary: Exclusive Breastfeeding Rates in Burkina Faso — 310; 161 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Peer-support for exclusive breastfeeding (Behavioral)
Age
Pediatric, Adult, Older Adult · 15+ yrs
Sex
All
Sponsor
Centre For International Health
Primary completion
Jul 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Exclusive Breastfeeding Rates in Burkina Faso
310; 161
PRIMARY
Infant Morbidity, 2 Week Diarrhoea Prevalence
104; 101
PRIMARY
Exclusive Breastfeeding Rates in Uganda
323; 161
PRIMARY
Exclusive Breastfeeding Rates in South Africa
56; 30
SECONDARY
Growth
SECONDARY
Per Protocol Analysis of EBF Rates
SECONDARY
Per Protocol Analysis of Infant Morbidity

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 of infant micronutrient status to see how they vary by feeding pattern, including EBF, for a longer period than has been examined previously.

Eligibility Criteria

Inclusion Criteria

  • Lives in a selected cluster
  • Is >= 6 months pregnant
  • Has no plans to move outside of the cluster within 1 year

Exclusion Criteria

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00397150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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