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Randomized Controlled Trial of Bovine Lactoferrin for Prevention of Sepsis and Neurodevelopment Impairment in Infants Weighing Less Than 2000 Grams

2020; Elsevier BV; Volume: 219; Linguagem: Inglês

10.1016/j.jpeds.2019.12.038

1097-6833

Theresa J. Ochoa, Jaime Zegarra, Sicilia Bellomo, César Cárcamo, Luis Cam, Anne Castañeda, Aasith Villavicencio, Jorge Gonzales, Maria S. Rueda, Christie G. Turin, Alonso Zea Vera, Daniel Guillén, Miguel Campos, Linda Ewing‐Cobbs, Pilar Medina, María Rivas, Irene Chea, Alícia Villar Aguilés, Carolina Navarro, Lourdes Tucto, Patricia Mallma, Renzo Calderón-Anyosa, María Luz Rospigliosi, G Borda, Orialit Minauro, Verónica Webb, Erika Bravo, Karen Pacheco, Ana Flávia de Souza Lino, Augusto Cama, Raúl Llanos, Oscar Chumbes, Liliana Cuba, Julio Tresierra, Carmen Chincaro, Alfredo Tori,

Neonatal Respiratory Health Research

Objectives To determine the effect of bovine lactoferrin on prevention of late-onset sepsis (LOS) and neurodevelopment delay. Study design Randomized, double-blind, controlled trial in neonates with a birth weight of 500-2000 g in 3 neonatal units in Lima, Peru, comparing bovine lactoferrin 200 mg/kg/day with placebo administered for 8 weeks. The primary outcome was the first episode of culture-proven LOS or sepsis-associated death. Neurodevelopment delay was assessed by the Mullen Scales at 24 months corrected age. Results Of the 414 infants enrolled, 209 received bovine lactoferrin and 205 received placebo. LOS or sepsis-associated death occurred in 22 infants (10.5%) in the bovine lactoferrin group vs 30 (14.6%) in the placebo group; there was no difference after adjusting for hospital and birth weight; hazard ratio 0.73 (95% CI, 0.42-1.26). For infants with birth weights of <1500 g the hazard ratio was 0.69 (95% CI, 0.39-1.25). The mean age-adjusted normalized Mullen composite score at 24 months was 83.3 ± 13.6 in the bovine lactoferrin group vs 82.6 ± 13.1 in the placebo group. Growth outcomes and rehospitalization rates during the 2-year follow-up were similar in both groups, except for significantly less bronchiolitis in the bovine lactoferrin group (rate ratio, 0.34; 95% CI, 0.14-0.86). Conclusions Supplementation with bovine lactoferrin did not decrease the incidence of sepsis in infants with birth weights of <2000 g. Growth and neurodevelopment outcomes at 24 months of age were similar. Neonatal bovine lactoferrin supplementation had no adverse effects. Trial registration ClinicalTrials.gov: NCT01525316.