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Kramer MS, Chalmers B, Hodnett ED, et al. Promotion of Breastfeeding Intervention Trial (PROBIT): A Randomized Trial in the Republic of Belarus. JAMA. 2001;285(4):413–420. doi:10.1001/jama.285.4.413
Author Affiliations: Departments of Pediatrics (Drs Kramer and Collet) and Epidemiology and Biostatistics (Drs Kramer, Shapiro, and Collet and Mr Ducruet), McGill University Faculty of Medicine, Montreal, Quebec; Centre for Research in Women's Health (Dr Chalmers), Sunnybrook and Women's College Health Sciences Centre (Dr Chalmers), and Faculty of Nursing (Dr Hodnett), University of Toronto, Toronto, Ontario; Departments of Maternal and Child Health (Drs Sevkovskaya, Mknuik, and Gluchanina) and Foreign Relations (Ms Mezen), Belarussian Ministry of Health and Belarussian Maternal and Child Health Research Institute (Drs Dzikovich, Vanilovich, Shishko, Zubovich, Dombrovskiy, Ustinovitch, Kot, and Bogdanovitch and Ms Ovchinikova), Minsk, Belarus; and the Nutrition Unit, World Health Organization Regional Office for Europe, Copenhagen, Denmark (Dr Helsing).
Context Current evidence that breastfeeding is beneficial for infant and child
health is based exclusively on observational studies. Potential sources of
bias in such studies have led to doubts about the magnitude of these health
benefits in industrialized countries.
Objective To assess the effects of breastfeeding promotion on breastfeeding duration
and exclusivity and gastrointestinal and respiratory infection and atopic
eczema among infants.
Design The Promotion of Breastfeeding Intervention Trial (PROBIT), a cluster-randomized
trial conducted June 1996–December 1997 with a 1-year follow-up.
Setting Thirty-one maternity hospitals and polyclinics in the Republic of Belarus.
Participants A total of 17 046 mother-infant pairs consisting of full-term singleton
infants weighing at least 2500 g and their healthy mothers who intended to
breastfeed, 16491 (96.7%) of which completed the entire 12 months of follow-up.
Interventions Sites were randomly assigned to receive an experimental intervention
(n = 16) modeled on the Baby-Friendly Hospital Initiative of the World Health
Organization and United Nations Children's Fund, which emphasizes health care
worker assistance with initiating and maintaining breastfeeding and lactation
and postnatal breastfeeding support, or a control intervention (n = 15) of
continuing usual infant feeding practices and policies.
Main Outcome Measures Duration of any breastfeeding, prevalence of predominant and exclusive
breastfeeding at 3 and 6 months of life and occurrence of 1 or more episodes
of gastrointestinal tract infection, 2 or more episodes of respiratory tract
infection, and atopic eczema during the first 12 months of life, compared
between the intervention and control groups.
Results Infants from the intervention sites were significantly more likely than
control infants to be breastfed to any degree at 12 months (19.7% vs 11.4%;
adjusted odds ratio [OR], 0.47; 95% confidence interval [CI], 0.32-0.69),
were more likely to be exclusively breastfed at 3 months (43.3% vs 6.4%; P<.001) and at 6 months (7.9% vs 0.6%; P = .01), and had a significant reduction in the risk of 1 or more
gastrointestinal tract infections (9.1% vs 13.2%; adjusted OR, 0.60; 95% CI,
0.40-0.91) and of atopic eczema (3.3% vs 6.3%; adjusted OR, 0.54; 95% CI,
0.31-0.95), but no significant reduction in respiratory tract infection (intervention
group, 39.2%; control group, 39.4%; adjusted OR, 0.87; 95% CI, 0.59-1.28).
Conclusions Our experimental intervention increased the duration and degree (exclusivity)
of breastfeeding and decreased the risk of gastrointestinal tract infection
and atopic eczema in the first year of life. These results provide a solid
scientific underpinning for future interventions to promote breastfeeding.