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

This study has been completed.
Sponsor:
Collaborators:
European Union
The Norwegian Programme for Development, Research and Higher Education
University of Bergen
Université Montpellier
Uppsala University
Centre Muraz
Makerere University
University of Zambia
University of the Western Cape
Information provided by:
Centre For International Health
ClinicalTrials.gov Identifier:
NCT00397150
First received: November 7, 2006
Last updated: May 5, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Diarrhea
Behavioral: Peer-support for exclusive breastfeeding

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Centre For International Health:

Primary Outcome Measures:
  • exclusive breastfeeding rates [ Time Frame: at 3 months of age ] [ Designated as safety issue: No ]
  • infant morbidity, 2 week diarrhoea prevalence [ Time Frame: at 3 months of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • growth [ Time Frame: (up to 6 months of age) ] [ Designated as safety issue: No ]
  • micronutrient status [ Time Frame: at 6 months of age ] [ Designated as safety issue: No ]
  • per protocol analysis of EBF rates [ Time Frame: at 3 months of age ] [ Designated as safety issue: No ]
  • per protocol analysis of infant morbidity [ Time Frame: at 3 months of age ] [ Designated as safety issue: No ]

Enrollment: 2579
Study Start Date: November 2006
Study Completion Date: April 2011
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Peer-counselling for exclusive breastfeeding
Behavioral: Peer-support for exclusive breastfeeding
Counselling to support exclusive breastfeeding up to the age of 6 months of age by the use of peer-counsellors in the local community
No Intervention: No intervention
No intervention

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00397150

Locations
Burkina Faso
Centre Muraz
Bobo-Dioulasso, Burkina Faso
South Africa
School of Public Health, University of the Western Cape (UWC)
Cape Town, South Africa
Uganda
Dept of Paediatrics and Child Health, Makerere University
Kampala, Uganda
Zambia
Dept of Paediatrics and Child Health, University of Zambia, School of Medicine (UNZA/SOM)
Lusaka, Zambia
Sponsors and Collaborators
Centre For International Health
European Union
The Norwegian Programme for Development, Research and Higher Education
University of Bergen
Université Montpellier
Uppsala University
Centre Muraz
Makerere University
University of Zambia
University of the Western Cape
Investigators
Principal Investigator: Thorkild Tylleskar, MD, PHD Centre For International Health
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Centre For International Health, University of Bergen
ClinicalTrials.gov Identifier: NCT00397150     History of Changes
Other Study ID Numbers: INCO-CT-2004-003660
Study First Received: November 7, 2006
Last Updated: May 5, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Centre For International Health:
Infant Nutrition [G06.696.259.750]
Infant Care [N02.421.088.120] +
Diarrhea, Infantile [C23.888.821.214.500]
Child Health Services [N02.421.143.130] +
Counseling [N02.421.143.303]
Growth [G07.574.249] +
Micronutrients [D11.430]
Breast Feeding [G06.696.259.750.500]

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 11, 2014