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 (Responsible Party):
Thorkild Tylleskar, Centre For International Health
ClinicalTrials.gov Identifier:
NCT00397150
First received: November 7, 2006
Last updated: February 20, 2015
Last verified: February 2015
Results First Received: December 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Diarrhea
Intervention: Behavioral: Peer-support for exclusive breastfeeding

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Pregnant women are recruited in their communities.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None.

Reporting Groups
  Description
Intervention Peer-counselling for exclusive breastfeeding
No Intervention Standard of care

Participant Flow:   Overall Study
    Intervention     No Intervention  
STARTED     1323     1256  
COMPLETED     1188     1111  
NOT COMPLETED     135     145  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intervention Peer-counselling for exclusive breastfeeding
No Intervention Standard of care
Total Total of all reporting groups

Baseline Measures
    Intervention     No Intervention     Total  
Number of Participants  
[units: participants]
  1323     1256     2579  
Age  
[units: participants]
     
<=18 years     1323     1256     2579  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: days]
Median ( Full Range )
  7  
  ( 5 to 9 )  
  7  
  ( 5 to 9 )  
  7  
  ( 5 to 9 )  
Gender  
[units: participants]
     
Female     662     628     1290  
Male     661     628     1289  
Region of Enrollment  
[units: participants]
     
Burkina Faso     392     402     794  
Uganda     396     369     765  
South Africa     535     485     1020  



  Outcome Measures
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1.  Primary:   Exclusive Breastfeeding Rates in Burkina Faso   [ Time Frame: at 3 months of age ]

2.  Primary:   Infant Morbidity, 2 Week Diarrhoea Prevalence   [ Time Frame: at 3 months of age ]

3.  Primary:   Exclusive Breastfeeding Rates in Uganda   [ Time Frame: at 3 months of age ]

4.  Primary:   Exclusive Breastfeeding Rates in South Africa   [ Time Frame: at 3 months of age ]

5.  Secondary:   Growth   [ Time Frame: (up to 6 months of age) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Per Protocol Analysis of EBF Rates   [ Time Frame: at 3 months of age ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Per Protocol Analysis of Infant Morbidity   [ Time Frame: at 3 months of age ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Trial not entirely blinded.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Prof Thorkild Tylleskar
Organization: Centre for International Health, University of Bergen, Norway
phone: +47 55588562
e-mail: Thorkild.Tylleskar@cih.uib.no


Publications of Results:

Other Publications:

Publications automatically indexed to this study:

Responsible Party: Thorkild Tylleskar, Centre For International Health
ClinicalTrials.gov Identifier: NCT00397150     History of Changes
Other Study ID Numbers: INCO-CT-2004-003660
Study First Received: November 7, 2006
Results First Received: December 18, 2012
Last Updated: February 20, 2015
Health Authority: Norway:National Committee for Medical and Health Research Ethics