1Neonatology and NICU, S Anna Hospital, AOU Città della Salute e della Scienza, Torino, Italy2Neonatology and NICU, Complejo Asistencial Universitario de Salamanca, Salamanca, Spain3Neonatology and NICU, Middlemore Hospital, Auckland, New Zealand4Neonatology, Azienda Ospedaliera Universitaria Policlinico Umberto I, Rome, Italy5NICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy6Neonatology and NICU, Ospedale Regionale, Bolzano/Bozen, Italy7NICU, University of Modena and Reggio Emilia, Modena, Italy8NICU, Azienda Ospedaliera Universitaria Policlinico di Catania, Italy9UOC di Pediatria e Patologia Neonatale, Ospedale San Martino, Belluno, Italy10Patologia Neonatale, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy11Neonatology, Ospedali Riuniti, Foggia, Italy12Cancer Epidemiology Unit, University of Turin, Department of Medical Sciences, Torino, Italy13Cancer Epidemiology Unit, University of Turin, Torino, Italy14Department of Pediatrics, University of Turin, Torino, Italy
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ObjectiveTo investigate whether exposure to inhibitors of gastric acidity, such as H2 blockers or proton pump inhibitors, can independently increase the risk of infections in very low birth weight (VLBW) preterm infants in the neonatal intensive care unit.Study designThis is a secondary analysis of prospectively collected data from a multicenter, randomized controlled trial of bovine lactoferrin (BLF) supplementation (with or without the probiotic Lactobacillus rhamnosus GG) vs placebo in prevention of late-onset sepsis (LOS) and necrotizing enterocolitis (NEC) in preterm infants. Inhibitors of gastric acidity were used at the recommended dosages/schedules based on the clinical judgment of attending physicians. The distribution of days of inhibitors of gastric acidity exposure between infants with and without LOS/NEC was assessed. The mutually adjusted effects of birth weight, gestational age, duration of inhibitors of gastric acidity treatment, and exposure to BLF were controlled through multivariable logistic regression. Interaction between inhibitors of gastric acidity and BLF was tested; the effects of any day of inhibitors of gastric acidity exposure were then computed for BLF-treated vs -untreated infants.ResultsTwo hundred thirty-five of 743 infants underwent treatment with inhibitors of gastric acidity, and 86 LOS episodes occurred. After multivariate analysis, exposure to inhibitors of gastric acidity remained significantly and independently associated with LOS (OR, 1.03; 95% CI, 1.008-1.067; P = .01); each day of inhibitors of gastric acidity exposure conferred an additional 3.7% odds of developing LOS. Risk was significant for Gram-negative (P < .001) and fungal (P = .001) pathogens, but not for Gram-positive pathogens (P = .97). On the test for interaction, 1 additional day of exposure to inhibitors of gastric acidity conferred an additional 7.7% risk for LOS (P = .003) in BLF-untreated infants, compared with 1.2% (P = .58) in BLF-treated infants.ConclusionExposure to inhibitors of gastric acidity is significantly associated with the occurrence of LOS in preterm VLBW infants. Concomitant administration of BLF counteracts this selective disadvantage.Trial registrationisrctn.org: ISRCTN53107700.