Promotion of Breastfeeding Intervention Trial (PROBIT)
- Canadian Institutes of Health Research
- National Institutes of Health (NIH)
Project Summary
The Promotion of Breastfeeding Intervention Trial (PROBIT) is the largest cluster-randomized controlled trial ever conducted in the area of human lactation.
Breastfeeding, compared with formula feeding, has been suggested to yield benefits for children’s immune system, growth, cognitive development, and behavior. The aim of PROBIT is to investigate the influence of breastfeeding on health outcomes within a randomized controlled trial in which the randomized arms differ substantially with respect to the duration and exclusivity of breastfeeding.
Project Details
The PROBIT trial is based on the long-term follow-up of healthy mothers and infants who were originally enrolled into the trial in the Republic of Belarus. Thirty-one maternity hospitals and one of their affiliated polyclinics were randomized either to a breastfeeding promotion intervention modeled on the WHO/UNICEF Baby-Friendly Hospital Initiative, or to the control arm, in which the maternity hospitals and polyclinics continued the breastfeeding practices that prevailed at the time of randomization. A total of 17,046 subjects were recruited from the 31 randomized sites.
Because all infants were initially breastfed, the experimental intervention was designed to increase the duration and exclusivity of breastfeeding. The intervention produced two randomized cohorts with substantially different duration and exclusivity of breastfeeding, providing a unique opportunity to test the effects of breastfeeding on health outcomes in intention-to-treat analyses. PROBIT investigators followed mothers and children for almost 20 years, and produced numerous high impact publications from intention to treat analyses demonstrating effects of the intervention on health outcomes most relevant to children. Additional observational analyses of the PROBIT cohort have yielded important insights into other early life influences on child health beyond breastfeeding.
Interested in Using PROBIT Data?
Please review and complete the data access agreement, then contact one of the Principal Investigators:
- Emily Oken
- Michael Kramer (McGill University)
- Richard Martin (University of Bristol)
Explore The Research
Explore findings, publications, and study documents spanning from infancy through adolescence, tracking the long-term effects of breastfeeding promotion on health and development
PROBIT Publications
From the landmark human lactation study that launched a continuously growing list of publications: the key findings.