The Promotion of Breastfeeding Intervention Trial (PROBIT) is the largest cluster-randomised controlled trial ever conducted in the area of human lactation during infancy.
The trial is based on the long-term follow-up of 17,046 healthy mothers and infants who were originally enrolled into the trial in the Republic of Belarus (PROBIT I, Principal Investigator: Professor Michael Kramer, McGill University, Canada).
31 maternity hospitals and one each of their affiliated polyclinics (where children are followed for routine health care) were randomised either to the experimental intervention of breastfeeding promotion or the control arm of continuing the prevailing breastfeeding practices at the time of randomisation.
The intervention produced two randomised cohorts with substantially different exposure to breastfeeding, providing a unique opportunity to test, in an intention to treat analysis, the affects of breastfeeding on health outcomes.
PROBIT IV will examine growth, obesity, blood pressure, neurocognitive function, vision, eczema and lung function.