| Study characteristics |
| Methods |
Prospective, single‐centre, double‐blind, randomized controlled trial |
| Participants |
Inborn neonates, birth weight < 1500 g or gestational age < 32 weeks. Exclusion criteria were lack of parental consent, severe congenital malformations, and severe HIE or death before 72 hours of life. |
| Interventions |
Bovine lactoferrin (200 mg/d) or placebo (2 mL of saline) once a day until discharge |
| Outcomes |
Primary outcomes: nosocomial sepsis as defined by CDC criteria, NEC stage II. Secondary outcomes: safety (feeding tolerance, abdominal distention, emesis, and gastric residuals), length of hospital stay, maturation of Treg levels |
| Notes |
Ankara University, Turkey; conducted between December 2009 and January 2011 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not reported |
| Allocation concealment (selection bias) |
Unclear risk |
Not reported |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Clinicians and outcome assessors were unaware of study groups. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Analysed data from 47/50 enrolled neonates |
| Selective reporting (reporting bias) |
Low risk |
None noted |
| Other bias |
Low risk |
None noted |
| Completeness of follow‐up |
Low risk |
Followed up 47/50 enrolled neonates |
| Blinding of outcome assessment |
Low risk |
Coordinator who was blinded to the study group assessed outcomes. |
