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Promotion of Breastfeeding Intervention Trial (Probot): A Cluster-Randomized Trial in the Republic of Belarus

Design, Follow-Up, and Data Validation

  • Chapter
Short and Long Term Effects of Breast Feeding on Child Health

Part of the book series: Advances in Experimental Medicine and Biology ((AEMB,volume 478))

Abstract

This paper summarizes the objectives, design, follow-up, and data validation of a cluster-randomized trial of a breastfeeding promotion intervention modeled on the WHO/UNICEF Baby-Friendly Hospital Initiative (BFHI). Thirty-four hospitals and their affiliated polyclinics in the Republic of Belarus were randomized to receive BFHI training of medical, midwifery, and nursing staffs (experimental group) or to continue their routine practices (control group). All breastfeeding mother-infant dyads were considered eligible for inclusion in the study if the infant was singleton, bom at 237 weeks gestation, weighed ≥2500 grams at birth, and had a 5-minute Apgar score ≥5, and neither mother nor infant had a medical condition for which breastfeeding was contraindicated. One experimental and one control site refused to accept their randomized allocation and dropped out of the trial. A total of 17,795 mothers were recruited at the 32 remaining sites, and their infants were followed up at 1, 2, 3, 6, 9, and 12 months of age. To our knowledge, this is the largest randomized trial ever undertaken in area of human milk and lactation. Monitoring visits of all experimental and control maternity hospitals and polyclinics were undertaken prior to recruitment and twice more during recruitment and follow-up to ensure compliance with the randomized allocation. Major study outcomes include the occurrence of ≥1 episode of gastrointestinal infection, ≥2 respiratory infections, and the duration of breastfeeding, and are analyzed according to randomized allocation (“intention to treat”). One of the 32 remaining study sites was dropped from the trial because of apparently falsified follow-up data, as suggested by an unrealistically low incidence of infection and unrealistically long duration of breastfeeding, and as confirmed by subsequent data audit of polyclinic charts and interviews with mothers of 64 randomly-selected study infants at the site. Smaller random audits at each of the remaining sites showed extremely high concordance between the PROBIT data forms and both the polyclinic charts and maternal interviews, with no evident difference in under- or over-reporting in experimental vs control sites. Of the 17,046 infants recruited from the 31 participating study sites, 16,491 (96.7%) completed the study and only 555 (3.3%) were lost to follow-up. PROBIT’s results should help inform decision making for clinicians, hospitals, industry, and governments concerning the support, protection, and promotion of breastfeeding.

the Nutrition Unit, World Health Organization Regional Office for Europe

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Author information

Authors and Affiliations

  1. Department of Pediatrics, McGill University Faculty of Medicine, Montreal, Canada

    M S Kramer & J-P Collet

  2. Department of Epidemiology & Biostatistics, McGill University Faculty of Medicine, Montreal, Canada

    M S Kramer, S Shapiro, J-P Collet & T Ducruet

  3. Centre for Research in Women’s Health, University of Toronto, Toronto, Canada

    B Chalmers & E D Hodnett

  4. Department of Maternal and Child Health, Belarussian Ministry of Health, Belarus

    Z Sevkovskaya, D Mknuik, E Gluchanina, V Dombrovsky, A Ustinovitch, T K, N Bogdanovich & L Ovchinikova

  5. Belarussian Maternal and Child Health Research Institute, Belarus

    I Dzikovich, I Vanilovich, G Shishko & V Zubovich

  6. Department of Foreign Relations, Belarussian Ministry of Health, Belarus

    I Mezen

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  1. M S Kramer
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  2. B Chalmers
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  7. J-P Collet
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  8. I Vanilovich
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  9. I Mezen
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  14. E Gluchanina
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  15. V Dombrovsky
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  16. A Ustinovitch
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  17. T K
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  19. L Ovchinikova
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Helsing E for the PROBIT Study Group

Editor information

Editors and Affiliations

  1. University of Munich, Munich, Germany

    Berthold Koletzko

  2. The Royal Veterinary and Agricultural University, Frederiksberg, Denmark

    Kim Fleischer Michaelsen

  3. University of Ume^, Ume005E;, Sweden

    Olle Hernell

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© 2002 Kluwer Academic Publishers

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Kramer, M.S. et al. (2002). Promotion of Breastfeeding Intervention Trial (Probot): A Cluster-Randomized Trial in the Republic of Belarus. In: Koletzko, B., Michaelsen, K.F., Hernell, O. (eds) Short and Long Term Effects of Breast Feeding on Child Health. Advances in Experimental Medicine and Biology, vol 478. Springer, Boston, MA. https://doi.org/10.1007/0-306-46830-1_28

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  • DOI: https://doi.org/10.1007/0-306-46830-1_28

  • Publisher Name: Springer, Boston, MA

  • Print ISBN: 978-0-306-46405-8

  • Online ISBN: 978-0-306-46830-8

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