Griffiths J, et al. - Investigators studied to estimate the impacts of enteral lactoferrin supplementation in very preterm newborns. They observed no reduction in the risk of late-onset infection in very preterm babies when they were given enteral supplementation with bovine lactoferrin. Therefore, they did not recommend the routine practice of such supplementation with the purpose to prevent late-onset infection and related morbidity or mortality in very preterm children.

Methods

• From 37 UK hospitals, very preterm infants born before 32 weeks' gestation (younger than 72 h at randomisation) were scrutinized for this randomized placebo-controlled trial.
• They conducted the trial with some exclusion criteria like presence of a severe congenital abnormality, anticipated enteral fasting for more than 14 days, or no realistic prospect of survival.
• They assigned the eligible newborns randomly (1:1) to receive either enteral bovine lactoferrin (150 mg/kg per day; maximum 300 mg/day; lactoferrin group) or sucrose (same dose; control group) once daily until 34 weeks' postmenstrual age.
• They minimized the web-based randomization for recruitment site, pregnancy period (completed weeks), sex, and single vs multifetal pregnancy.
• Parents, caregivers, and result analysts were not aware of group assignment.
• They confirmed the primary consequences as microbiologically or clinically suspected late-onset infection (occurring >72 h after birth).
• They calculated the relative risk ratio with 95% CI between the two groups in for whom primary outcome data was available

Results

• A sum of 2203 candidates were scrutinized from May 7, 2014, to Sept 28, 2017, among them 1099 were assigned to the lactoferrin group and 1104 to the control group.
• Among both the groups, 4 newborns had consent withdrawn or unconfirmed and left with 1098 children in the lactoferrin group and 1101 in the sucrose group.
• They availed the primary consequent data for 2182 individuals (1093 [99·5%] of 1098 in the lactoferrin group and 1089 [99·0%] of 1101 in the control group) for inclusion in the modified intention-to-treat analyses.
• Among 1093 babies, 316 (29%) candidate acquired a late-onset infection in the intervention group vs 334 (31%) of 1089 in the control group.
• They adjusted the risk ratio of 0·95 (95% CI 0·86–1·04; p=0·233) for minimization factors .
• They observed 16 serious adverse events for children in the lactoferrin group and 10 for those in the control group during the trial.
• They recorded a case of blood in stool and one death after intestinal perforation in the lactoferrin group.
• These 2 events were considered related to the trial intervention.