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1. Safety of Rotavirus Vaccination in Preterm Infants Admitted in Neonatal Intensive Care Units in Sicily, Italy: A Multicenter Observational Study

Author

Claudio Costantino, Arianna Conforto, Nicole Bonaccorso, Livia Cimino, Martina Sciortino, Mario Palermo, Kim Maiolo, Lucia Gabriella Tina, Pasqua Maria Betta, Mariacarmela Caracciolo, Carmine Mattia Loretta, Alessandro Arco, Eloisa Gitto, Salvino Marcello Vitaliti, Domenica Mancuso, Giuliana Vitaliti, Vincenzo Rosella, Giuseppa Pinello, Giovanni Corsello, Gregorio Serra, Bruna Gabriele, Fabio Tramuto, Vincenzo Restivo, Emanuele Amodio, and Francesco Vitale

Subjects
rotavirus, rotavirus gastroenteritis, hospitalizations, rotavirus vaccination, preterm infants, Medicine
Abstract

Rotavirus (RV) is among the most common vaccine-preventable diseases in children under five years of age. Despite the severity of rotavirus pathology in early childhood, rotavirus vaccination for children admitted to the neonatal intensive care unit (NICU), who are often born preterm and with various previous illnesses, is not performed. This multicenter, 3-year project aims to evaluate the safety of RV vaccine administration within the six main neonatal intensive care units of the Sicilian Region to preterm infants. Methods: Monovalent live attenuated anti-RV vaccination (RV1) was administered from April 2018 to December 2019 to preterm infants with gestational age ≥ 28 weeks. Vaccine administrations were performed in both inpatient and outpatient hospital settings as a post-discharge follow-up (NICU setting) starting at 6 weeks of age according to the official immunization schedule. Any adverse events (expected, unexpected, and serious) were monitored from vaccine administration up to 14 days (first assessment) and 28 days (second assessment) after each of the two scheduled vaccine doses. Results: At the end of December 2019, 449 preterm infants were vaccinated with both doses of rotavirus vaccine within the six participating Sicilian NICUs. Mean gestational age in weeks was 33.1 (±3.8 SD) and the first dose of RV vaccine was administered at 55 days (±12.9 SD) on average. The mean weight at the first dose was 3388 (SD ± 903) grams. Only 0.6% and 0.2% of infants reported abdominal colic and fever above 38.5 °C in the 14 days after the first dose, respectively. Overall, 1.9% EAEs were observed at 14 days and 0.4% at 28 days after the first/second dose administration. Conclusions: Data obtained from this study confirm the safety of the monovalent rotavirus vaccine even in preterm infants with gestational age ≥ 28 weeks, presenting an opportunity to improve the vaccination offer both in Sicily and in Italy by protecting the most fragile infants who are more at risk of contracting severe rotavirus gastroenteritis and nosocomial RV infection.

Published
2023
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3. Exposure to Gastric Acid Inhibitors Increases the Risk of Infection in Preterm Very Low Birth Weight Infants but Concomitant Administration of Lactoferrin Counteracts This Effect

Author

Paolo Manzoni, Ruben García Sánchez, Michael Meyer, Ilaria Stolfi, Lorenza Pugni, Hubert Messner, Silvia Cattani, Pasqua Maria Betta, Luigi Memo, Lidia Decembrino, Lina Bollani, Matteo Rinaldi, Maria Fioretti, Michele Quercia, Milena Maule, Elena Tavella, Alessandro Mussa, Chryssoula Tzialla, Nicola Laforgia, Fabio Mosca, Rosario Magaldi, Michael Mostert, Daniele Farina, Amelia Di Comite, Alessandro Borghesi, Giovanni Agriesti, Riccardo Arisio, Caterina Franco, Roberta Guardione, Elena Boano, Alessia Catarinella, Cristina Romano, Cesare Monetti, Ugo Sala, Caterina Carbonara, Emmanuele Mastretta, Paola Del Sordo, Claudio Priolo, Paolo Galletto, Francesca Campagnoli, Mauro Vivalda, Giuseppina Bonfante, Giovanna Gomirato, Davide Montin, Roberta Camilla, Alessandro Messina, Marta Pieretto, Domenico Cipolla, Mario Giuffrè, Giovanni Corsello, Fabio Natale, Gennaro Vetrano, Elisabetta Tridapalli, Giacomo Faldella, Maria Grazia Capretti, PierMichele Paolillo, Simonetta Picone, Serafina Lacerenza, Giancarlo Gargano, Cristiana Magnani, Onofrio Sergio Saia, Elena Della Casa, Manzoni, Paolo, García Sánchez, Ruben, Meyer, Michael, Stolfi, Ilaria, Pugni, Lorenza, Messner, Hubert, Cattani, Silvia, Betta, Pasqua Maria, Memo, Luigi, Decembrino, Lidia, Bollani, Lina, Rinaldi, Matteo, Fioretti, Maria, Quercia, Michele, Maule, Milena, Tavella, Elena, Mussa, Alessandro, Tzialla, Chryssoula, Laforgia, Nicola, Mosca, Fabio, Magaldi, Rosario, Mostert, Michael, Farina, Daniele, Giuffrè, Mario, Corsello, Giovanni, Manzoni P, García Sánchez R, Meyer M, Stolfi I, Pugni L, Messner H, Cattani S, Betta PM, Memo L, Decembrino L, Bollani L, Rinaldi M, Fioretti M, Quercia M, Maule M, Tavella E, Mussa A, Tzialla C, Laforgia N, Mosca F, Magaldi R, Mostert M, Farina D, and Di Comite A, Borghesi A, Agriesti G, Arisio R, Franco C, Guardione R, Boano E, Catarinella A, Romano C, Monetti C, Sala U, Carbonara C, Mastretta E, Del Sordo P, Priolo C, Galletto P, Campagnoli F, Vivalda M, Bonfante G, Gomirato G, Montin D, Camilla R, Messina A, Pieretto M, Cipolla D, Giuffrè M, Corsello G, Natale F, Vetrano G, Tridapalli E, Faldella G, Capretti MG, Paolillo P, Picone S, Lacerenza S, Gargano G, Magnani C, Sergio Saia O, Della Casa E

Subjects
Colonization, Proton Pump Inhibitor, Neonatal intensive care unit, Administration, Oral, Histamine H2 Antagonist, Probiotic, Gastroenterology, Pediatrics, H2 blocker, 0302 clinical medicine, Risk Factors, Infant, Very Low Birth Weight, 030212 general & internal medicine, Candida, VLBW neonate, Lacticaseibacillus rhamnosus, Gestational age, Perinatology and Child Health, Histamine H2 Antagonists, Italy, Necrotizing enterocolitis, medicine.symptom, Infection, Infant, Premature, Human, medicine.medical_specialty, Birth weight, Gastric Acid, Sepsis, 03 medical and health sciences, Enterocolitis, Necrotizing, Intensive Care Units, Neonatal, 030225 pediatrics, Internal medicine, medicine, H2 blockers, Humans, Dietary Supplement, business.industry, Risk Factor, Probiotics, Infant, Newborn, Proton Pump Inhibitors, medicine.disease, Low birth weight, Lactoferrin, Concomitant, Dietary Supplements, Pediatrics, Perinatology and Child Health, VLBW neonates, Gastric acid, Lactobacillus rhamnosu, business, New Zealand
Abstract

Objective: To 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 design: This 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. Results: Two 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. Conclusion: Exposure 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 registration: isrctn.org: ISRCTN53107700.

Published
2018

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