Bovine lactoferrin supplementation for prevention of necrotizing enterocolitis in very-low-birth-weight neonates: A randomized clinical trial
| Autor: | Luigi Memo, Lina Bollani, Livia Renzullo, Daniele Farina, Lorenza Pugni, Fabrizio Ferrari, Milena Maule, Fabio Mosca, Hubert Messner, Michael Mostert, Lidia Decembrino, Tanith Alexander, E. Gallo, Matteo Rinaldi, Michael P. Meyer, Rosario Magaldi, S Cattani, Mauro Stronati, Linda Bordignon, Federica Vagnarelli, Roberto Pedicino, Nicola Laforgia, Mario Giovanni Romeo, P Betta, Michele Quercia, Ilaria Stolfi, Paolo Manzoni |
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| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: |
Male
medicine.medical_specialty Placebo Gastroenterology law.invention Lactoferrin Necrotising enterocolitis Neonate Preterm Probiotics Sepsis Sepsis Necrotising enterocolitis Neonate Randomized controlled trial Anti-Infective Agents law Enterocolitis Necrotizing Preterm Internal medicine Intensive care medicine Animals Humans Infant Very Low Birth Weight Lactoferrin Probiotics Cattle Female Infant Newborn Pediatrics Perinatology and Child Health Obstetrics and Gynecology biology Obstetrics business.industry Incidence (epidemiology) medicine.disease digestive system diseases Low birth weight Necrotizing enterocolitis biology.protein medicine.symptom business |
| Popis: | NEC is a common and severe complication in premature neonates, particularly those with very-low-birth-weight (VLBW,1500 g at birth). Probiotics including lactobacillus rhamnosus GG (LGG) proved effective in preventing NEC in preterm infants in several RCTs.Lactoferrin, a mammalian milk glycoprotein involved in innate immune host defences, can reduce the incidence of NEC in animal models, and its action is enhanced by LGG. We tried to assess whether bovine lactoferrin (BLF), alone or with the probiotic LGG, has a similar effect in human infants, something that has not yet been studied.An international, multicenter, randomized, double-blind, placebo-controlled trial conducted from October 1st, 2007 through July 31st, 2010.Thirteen Italian and New Zealand tertiary neonatal intensive care units.743 VLBW neonates were assessed until discharge for development of NEC.Infants were randomly assigned to receive orally either BLF (100 mg/day) alone (group LF; n = 247) or with LGG (at 6×10(9) CFU/day; group BLF + LGG; n = 238), or placebo (Control group; n = 258) from birth until day 30 of life (45 for neonates1000 g at birth).≥ stage 2 NEC; death-and/or-≥ stage 2 NEC prior to discharge.Demographics, clinical and management characteristics of the 3 groups were similar, including type of feeding and maternal milk intakes. NEC incidence was significantly lower in groups BLF and BLF + LGG [5/247 (2.0%)] and 0/238 (0%), respectively] than in controls [14/258 (5.4%)] (RR = 0.37; 95% CI: 0.136-1.005; p = 0.055 for BLF vs. control; RR = 0.00; p0.001 for BLF + LGG vs. control). The incidence of death-and/or-NEC was significantly lower in both treatment groups (4.0% and 3.8% in BLF and BLF + LGG vs. 10.1% in control; RR = 0.39; 95% CI: 0.19-0.80; p = 0.008. RR = 0.37; 95% CI: 0.18-0.77; p = 0.006, respectively). No adverse effects or intolerances to treatment occurred.Compared with placebo, BLF supplementation alone or in combination with LGG reduced the incidence of ≥ stage 2 NEC and of death-and/or ≥ stage 2 NEC in VLBW neonates. BLF might be a promising strategy to prevent NEC in NICU settings. Further data on larger sample sizes are warranted before BLF can be widespreadly used in clinical settings.ISRCTN53107700-http://www.controlled-_trials.com/ISRCTN53107700. |
| Databáze: | OpenAIRE |
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