Magnesium Alginate in Gastro-Esophageal Reflux: A Randomized Multicenter Cross-Over Study in Infants

Maria Elisabetta Baldassarre, Antonio Di Mauro, Maria Cristina Pignatelli, Margherita Fanelli, Silvia Salvatore, Giovanni Di Nardo, Andrea Chiaro, Licia Pensabene and Nicola Laforgia
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Maria Elisabetta Baldassarre: Department of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, “Aldo Moro” University of Bari, 70124 Bari, Italy
Antonio Di Mauro: Department of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, “Aldo Moro” University of Bari, 70124 Bari, Italy
Maria Cristina Pignatelli: Department of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, “Aldo Moro” University of Bari, 70124 Bari, Italy
Margherita Fanelli: Department of Interdisciplinary Medicine, “Aldo Moro” University of Bari, 70100 Bari, Italy
Silvia Salvatore: Department of Pediatrics, “F. Del Ponte” Hospital, University of Insubria, 21100 Varese, Italy
Giovanni Di Nardo: Chiar of Pediatrics, NESMOS Department, School of Medicine and Psychology, Sapienza University of Rome, Sant’Andrea University Hospital, Via di Grottarossa 1035-1039, 00189 Rome, Italy
Andrea Chiaro: Department of Pediatrics, “Maggiore” Hospital, 26013 Crema, Italy
Licia Pensabene: Department of Medical and Surgical Sciences, Pediatric Unit, University “Magna Graecia” of Catanzaro, 88100 Catanzaro, Italy
Nicola Laforgia: Department of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, “Aldo Moro” University of Bari, 70124 Bari, Italy

IJERPH, 2019, vol. 17, issue 1, 1-9

Abstract: The aims of this study were to evaluate the efficacy of magnesium alginate in decreasing functional regurgitation symptoms in infants, and to assess the cost–benefit ratio of magnesium alginate compared to a thickened formula. A multicenter perspective cross-over study was conducted in formula-fed infants with persisting regurgitation, randomly assigned to receive two weeks of a magnesium-alginate-based formulation followed by two weeks of thickened formula, or vice-versa. Infants, exclusively breast-fed, were followed up for two weeks while receiving magnesium alginate. Symptoms of gastroesophageal reflux (GER) were evaluated through the Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R). Direct cost of treatments was also calculated. Seventy-two infants completed the study. We found a significant reduction of I-GERQ-R scores over time (F = 55.387; p < 0.001) in all groups with no difference between the sequences of administration (F = 0.268; p = 0.848) in formula-fed infants and between exclusively breast-fed and formula-fed infants receiving magnesium alginate (t = 1.55; p = 0.126). The mean cost savings per infant was € 4.60 (±11.2) in formula-fed infants treated with magnesium alginate compared to thickened formula (t = 2.91, p < 0.0005). Conclusions were that the magnesium-alginate formulation reduces GER symptoms both in formula-fed and breast-fed infants. In formula-fed infants, clinical efficacy is similar to thickened formulas with a slightly lower cost of treatment.

Keywords: infant regurgitation; magnesium alginate; thickened formula; breastfeeding (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2019
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