Sherman 2016.

Study characteristics
Methods	Phase 1 and Phase 2 randomized clinical trial
Participants	Preterm infants with birth weight of 750 to 1500 g in participating units in the United States, enrolled within 24 hours of birth
Interventions	Infants were given enteral human recombinant lactoferrin (talactoferrin, TLF) or placebo from day 1 to 29 days of life at a dose of 300 mg/kg/d.
Outcomes	Primary outcomes: reduction in hospital‐acquired infection; bacteremia, meningitis, pneumonia, urinary tract infection, necrotizing enterocolitis Secondary outcomes: mortality, duration of hospitalization, time to regain birth weight, time to reach full enteral feeds
Notes	Trial ID: ClinicalTrials.gov Identifier: NCT00854633 Trial was conducted in participating units in the United States, between July 1, 2009, and March 17, 2012.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomly assigned by a central computer system
Allocation concealment (selection bias)	Low risk	Centrally randomized
Blinding (performance bias and detection bias) All outcomes	Low risk	Double‐blinded study
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants accounted for
Selective reporting (reporting bias)	Low risk	None noted
Other bias	Low risk	None noted
Completeness of follow‐up	Low risk	All primary and secondary outcomes assessed during hospital stay
Blinding of outcome assessment	Unclear risk	Not explicit