Theresa J Ochoa1, Jaime Zegarra2, Sicilia Bellomo2, Cesar P Carcamo3, Luis Cam4, Anne Castañeda5, Aasith Villavicencio6, Jorge Gonzales6, Maria S Rueda6, Christie G Turin6, Alonso Zea-Vera6, Daniel Guillen2, Miguel Campos7, Linda Ewing-Cobbs8. 1. Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru; Instituto de Medicina Tropical "Alexander von Humboldt", Universidad Peruana Cayetano Heredia, Lima, Peru; Center for Infectious Diseases, School of Public Health, University of Texas Health Science Center at Houston, Houston, TX. Electronic address: Theresa.Ochoa@upch.pe. 2. Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru; Department of Pediatrics, Hospital Cayetano Heredia, Lima, Peru. 3. School of Public Health and Administration, Universidad Peruana Cayetano Heredia, Lima, Peru. 4. Department of Pediatrics, Hospital Nacional Alberto Sabogal, Lima, Peru. 5. Department of Pediatrics, Hospital Nacional Guillermo Almenara, Lima, Peru. 6. Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru. 7. Department of Mathematics, School of Science and Philosophy, Universidad Peruana Cayetano Heredia, Lima, Peru. 8. Department of Pediatrics and Children's Learning Institute, School of Medicine, University of Texas Health Science Center at Houston, Houston, TX.
Abstract
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, comparingbovine 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 receivedbovine 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.
RCT Entities:
OBJECTIVES: To determine the effect of bovinelactoferrin 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 bovinelactoferrin 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 bovinelactoferrin and 205 received placebo. LOS or sepsis-associated death occurred in 22 infants (10.5%) in the bovinelactoferrin 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 bovinelactoferrin 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 bovinelactoferrin group (rate ratio, 0.34; 95% CI, 0.14-0.86). CONCLUSIONS: Supplementation with bovinelactoferrin 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 bovinelactoferrin supplementation had no adverse effects. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01525316.
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