NCT01821989.

Study name	Oral lactoferrin supplementation for prevention of sepsis in preterm neonates
Methods	Double‐blind, randomized, controlled trial
Participants	Preterm neonates with birth weight between 500 g and 2500 g and ≤ 36 weeks' gestation, born in or referred to the neonatal intensive care unit of one of the participating hospitals in the first 48 hours of life Exclusion criteria: neonates with underlying gastrointestinal problems that prevent oral intake, neonates with predisposing conditions that profoundly affect growth and development (chromosomal abnormalities, structural brain anomalies, severe congenital abnormalities), neonates with a family background of cow's milk allergy, neonates who will not have the chance to complete the study time (who will be referred to another hospital), neonates whose parents decline to participate, neonates with early‐onset sepsis
Interventions	Preterm neonates will be randomly assigned to 1 of 3 groups: low‐dose lactoferrin (100 mg/d), high‐dose lactoferrin (150 mg/kg/twice daily), or placebo (distilled water).
Outcomes	Primary outcome: blood culture positivity Secondary outcome: complete blood count with differential leukocyte count and C‐reactive protein quantitative assay
Starting date	June 2013 and plans to enroll 180 neonates
Contact information	Mostafa AM Elmokadem: drmooselmokadem@hotmail.com; Egypt: Ain Shams University
Notes	Trial ID: ClinicalTrials.gov identifier: NCT01821989

BLF: bovine lactoferrin
BPD: bronchopulmonary dysplasia
NEC: necrotizing enterocolitis
ROP: retinopathy of prematurity