Probiotic treatment versus placebo to risk newborns for prevention of infant mortality or undernutrition - a two-arm multi-center superiority randomized controlled trial

Undernutrition is linked to half of global child mortality. Many of these malnourished children are also born premature and/or with a low birth weight (LBW).

To reach the SDGs 2 and 3, that aim to end all forms of malnutrition and stop preventable newborn deaths before 2030, established interventions are not sufficient. Hence, innovative, safe and acceptable evidence-based interventions must be developed.

Probiotics are routine practice to prevent mortality in preterm and small for gestational age newborns in high income countries.

Evidence shows that the impact could be even larger in LMICs and can simultaneously address both mortality and undernutrition.

Aim: An RCT on a birth cohort generated from an electronic medical birth register in Rwanda, where we will compare risk newborn outcomes in a placebo (standard care) group (n≈700) with an intervention group (n≈700) that will receive daily probiotics during the first two weeks of life.

Methods: After proxy consent, inclusion of risk newborns (defined as LBW, preterm, or having a malnourished mother) will be made at 1-7 days of age before discharge from one of the ten birth health facilities.

Follow up visits to register outcome (death/undenutrition) will be performed by a study nurse in the participant homes on 4-6 weeks, 12, and 24 months of age.

Impact: The study could generate evidence for an intervention that is safe, easily administrable and saving lives where the need is highest.