Study name	Evaluation of the effect of probiotics on late‐onset sepsis in very preterm newborns
Methods	A randomized, triple blinded, placebo controlled clinical trial with two parallel groups
Participants	Inclusion criteria include: 1. Preterm infants weighting 1000‐1500 g and <32 weeks’ gestational age at birth 2. Enrolled within 48 h of birth
	Exclusion criteria: (a) Major congenital anomalies (Esophageal atresia,omphalocele, imperforate anus). (2) Major congenital heart malformations. (3) Genetic anomalies(e.g. Trisomy 21 or other trisomies). (4) Considered likely to die within 72 h of birth. (5) Death before minimal entral feeding (10‐20cc/kg/day). (6) Parents from whom informed consent cannot be obtained. (7) Sepsis in admission (CRP > 10 mg/dl in 1th day of admission). (8) Asphyxia (grade II, III). (9) Maternal chorioamnionitis
Interventions	Very low‐birth‐weight preterm infants with a gestational age of <32 weeks and a weight of 1000‐1500 gr who are admitted to the NICU of Shahid Motahari Hospital in Urmia during the first 48 h of their birth. Patients are randomly divided into two groups; the intervention group receive probiotic and the control group receive Dish water as placebo
Outcomes	Late onset sepsis
Starting date	2018‐03‐05
Contact information	Kamran Dehghan
	Iran (Islamic Republic of)
	dehghan.k@umsu.ac.ir
Notes