This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

The primary objective is to identify and summarize the evidence from randomized controlled trials that compared the effectiveness and safety of prophylactic enteral probiotics administration versus placebo or no treatment in the prevention of severe (stage II or more) NEC and/or sepsis preterm infants. The secondary objective is to conduct a subgroup analysis to investigate the effect of probiotics in Extreme Low Birth Weight (ELBW < 1000 gm) infants.