Enteral lactoferrin supplementation for very preterm infants: a randomised placebo-controlled trial

Study answer

What this study found

Enteral bovine lactoferrin did not reduce late-onset infection or improve major neonatal outcomes in very preterm infants, so routine use is not supported. The primary outcome occurred in 316/1093 (29%) in the lactoferrin group versus 334/1089 (31%) in the control group, with unadjusted RR 0.95 (95% CI 0.86-1.04; p=0.233). There was also no meaningful difference in all-cause mortality (71/1076 [7%] vs 68/1076 [6%]; RR 1.04, 0.69-1.59), NEC (63/1085 [6%] vs 56/1084 [5%]; RR 1.12, 0.71-1.77), severe ROP (64/1080 [6%] vs 72/1080 [7%]; RR 0.89, 0.58-1.35), BPD at 36 weeks' postmenstrual age…

Study & population

Randomised placebo-controlled trial in very preterm infants born before 32 weeks' gestation and enrolled within 72 hours of birth at 37 neonatal units in the UK.

Intervention

Bovine lactoferrin was given enterally at 150 mg/kg bodyweight per day, up to a maximum of 300 mg/day, once daily via gastric tube until 34 weeks' postmenstrual age.

Key limitation

The trial was conducted in very preterm infants in UK neonatal units, which may limit generalisability to other settings.

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Original abstract