Enteral lactoferrin to prevent infection for very preterm infants: the ELFIN RCT

Grif­fiths et al, Health Tech­nol­o­gy Assess­ment,Decem­ber 2018

Abstract

Background

Infec­tions acquired in hos­pi­tal are an impor­tant cause of mor­bid­i­ty and mor­tal­i­ty in very preterm infants. Sev­er­al small tri­als have sug­gest­ed that sup­ple­ment­ing the enter­al diet of very preterm infants with lacto­fer­rin, an antimi­cro­bial pro­tein processed from cow’s milk, pre­vents infec­tions and asso­ci­at­ed com­pli­ca­tions.

Objective

To deter­mine whether or not enter­al sup­ple­men­ta­tion with bovine lacto­fer­rin (The Tat­ua Coop­er­a­tive Dairy Com­pa­ny Ltd, Mor­rinsville, New Zealand) reduces the risk of late-onset infec­tion (acquired > 72 hours after birth) and oth­er mor­bid­i­ty and mor­tal­i­ty in very preterm infants.

Ran­domised, place­bo-con­trolled, par­al­lel-group tri­al. Ran­domi­sa­tion was via a web-based por­tal and used an algo­rithm that min­imised for recruit­ment site, weeks of ges­ta­tion, sex and sin­gle ver­sus mul­ti­ple births.

Results

Of 2203 enrolled infants, pri­ma­ry out­come data were avail­able for 2182 infants (99%). In the inter­ven­tion group, 316 out of 1093 (28.9%) infants acquired a late-onset infec­tion ver­sus 334 out of 1089 (30.7%) infants in the con­trol group [adjust­ed risk ratio (RR) 0.95, 95% con­fi­dence inter­val (CI) 0.86 to 1.04]. There were no sig­nif­i­cant dif­fer­ences in any sec­ondary out­comes: micro­bi­o­log­i­cal­ly con­firmed infec­tion (RR 1.05, 99% CI 0.87 to 1.26), mor­tal­i­ty (RR 1.05, 99% CI 0.66 to 1.68), NEC (RR 1.13, 99% CI 0.68 to 1.89), ROP (RR 0.89, 99% CI 0.62 to 1.28), BPD (RR 1.01, 99% CI 0.90 to 1.13), or a com­pos­ite of infec­tion, NEC, ROP, BPD and mor­tal­i­ty (RR 1.01, 99% CI 0.94 to 1.08). There were no dif­fer­ences in the num­ber of days of receipt of antimi­cro­bials, length of stay in hos­pi­tal, or length of stay in inten­sive care, high-depen­den­cy or spe­cial-care set­tings. There were 16 reports of seri­ous adverse events for infants in the lacto­fer­rin group and 10 for infants in the sucrose group.

Conclusions

Enter­al sup­ple­men­ta­tion with bovine lacto­fer­rin does not reduce the inci­dence of infec­tion, mor­tal­i­ty or oth­er mor­bid­i­ty in very preterm infants.

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