| Study characteristics |
| Methods |
Single‐centre, randomized, placebo‐controlled trial |
| Participants |
Inborn neonates admitted in the first 12 hours of birth with no maternal risk factors for sepsis were enrolled. Exclusion criteria were congenital anomalies, severe birth asphyxia, history of maternal chorioamnionitis, suspected congenital infection, family history of cow's milk allergy. Neonates with culture‐proven early‐onset sepsis were also excluded. |
| Interventions |
Infants were randomized to bovine lactoferrin (100‐250 mg/d based on birth weight) or placebo once daily for the first 28 days of life. |
| Outcomes |
Primary outcome: culture‐proven late‐onset sepsis. Secondary outcomes: probable late‐onset sepsis, any late‐onset sepsis, sepsis‐attributed mortality |
| Notes |
Conducted in northern India between May 2012 and June 2013 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
randomization by a computer‐generated random table |
| Allocation concealment (selection bias) |
Low risk |
Sealed envelope method |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Physician and parents were blinded. Study drug and placebo sachets with lactoferrin were similar in appearance and were prepared by the hospital pharmacy. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Attrition rate: < 10% accounted for in the analysis |
| Selective reporting (reporting bias) |
Low risk |
None noted |
| Other bias |
Low risk |
None noted |
| Completeness of follow‐up |
Low risk |
Loss to follow‐up < 10% |
| Blinding of outcome assessment |
Unclear risk |
Blinding of outcome assessors was not explicit. |
