Jacques Rigo, M. Radke, Fabio Mosca, Jean Michel Hascoët, Jean Charles Picaud, Umberto Simeoni, Nicholas P. Hays, Mickaël Hartweg, Elie Saliba, Johannes Spalinger, Claude Billeaud, Bernard Guillois, Amandine Rubio, Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Institut National de la Recherche Agronomique (INRA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hospices Civils de Lyon (HCL), AZTI-Tecnalia (Marine Research Division), AZTI-Tecnalia, Centre Hospitalier Universitaire Vaudois [Lausanne] (CHUV), Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Institut National de la Recherche Agronomique (INRA), Department of Neonatology [London], Institute for Women's Health [London], University College London Hospitals (UCLH)-University College London Hospitals (UCLH), Maternité Régionale Adolphe Pinard [Nancy], Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon (HCL), Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Centre Hospitalier Universitaire [Grenoble] (CHU), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Hôpital Georges Clémenceau, Nestlé Product Technology Center, CHU de Bordeaux Pellegrin [Bordeaux], and Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS)
International audience; Aim: This study examined the influence of different human milk fortifiers on biomarkers of gastrointestinal immaturity and inflammation in preterm infants.Methods: We report secondary outcomes from a controlled, double‐blind, randomised, parallel group study conducted from 2011 to 2014 in neonatal intensive care units at 11 metropolitan hospitals in France, Belgium, Germany, Switzerland and Italy. Preterm infants born at up to 32 weeks or weighing up to 1500 g were randomised to a new powdered human milk fortifier (n = 77) or a control fortifier (n = 76) for a minimum of 21 days. We analysed faecal markers of gut inflammation, namely alpha‐1 antitrypsin and calprotectin, and maturity, namely elastase‐1.Results: Faecal alpha‐1 antitrypsin was slightly lower in the new than control fortifier group after 21 days of full enteral feeding, with a geometric mean and standard deviation of 1.52 ± 1.32 vs 1.82 ± 1.44 mg/g stools (P = .01). There was no significant difference in faecal calprotectin (median [Q1‐Q3] of 296 [136‐565] μg/g stools in both groups combined at study day 21). Faecal elastase‐1 was lower in the new fortifier than control fortifier group (202.5 ± 1.6 vs 257.7 ± 1.5 μg/g stools, P = .016).Conclusion: Mean values for each parameter were within the ranges in healthy term infants, indicating favourable markers of gastrointestinal status in both groups. In addition, for faecal calprotectin, the relatively high concentration observed in preterm infants fed fortified human milk suggests that the threshold level for detecting necrotising enterocolitis should be revised.