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Design: randomised clinical trial.1
Allocation: concealed (web-based randomisation).
Blinding: parents, clinicians, investigators and outcome assessors were blinded.
Setting: 37 neonatal units in the UK.
Patients: infants born before 32 weeks gestation. Exclusion criteria were a severe congenital abnormality, an expected fast of over 14 days or no realistic chance of survival. A total of 2203 babies were enrolled for a target sample size of 2200.
Intervention: placebo versus supplementing enteral feeds with 150 mg/kg/day of bovine lactoferrin once the infant was feeding over 12 mL/kg/day. This was continued until 34 weeks corrected gestation.
Outcomes: the primary outcome was microbiologically confirmed or clinically suspected late-onset sepsis (LOS) (assessed locally initially, then by a central review committee) from trial entry to hospital discharge. Secondary outcomes were numerous but included necrotising enterocolitis (NEC), bronchopulmonary dysplasia (BPD), length of stay and mortality predischarge. Composite outcomes were also analysed.
Follow-up period: …
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