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Table 1 Overview of inclusion and exclusion criteria

From: NutriBrain: protocol for a randomised, double-blind, controlled trial to evaluate the effects of a nutritional product on brain integrity in preterm infants

Inclusion criteria

 1) Gestational age of 24 + 0 to < 30 + 0 weeks

 2) Less than 72 h old and the intention to receive the first administration of study product between 48 and 72 h after birth

 3) Written informed consent from custodial parent(s)

Exclusion criteria

 1) Any relevant proven or suspected chromosomal anomaly, metabolic disorder, genetic syndrome or congenital central nervous system malformation

 2) Presence of any gastrointestinal malformation

 3) No realistic prospect of survival (e.g. severe brain injury), at the discretion of the attending physician

 4) Concomitant participation in other intervention studies (for example, but not exclusively, those studies involving investigational or marketed nutritional or pharmaceutical products) that could impact on the main outcome parameters and/or infant safety

 5) Expected or foreseen inability of the infant and/or their families to adhere to protocol instructions

 6) Admission from an extra regional hospital, unless that hospital is a study site

 7) Current use of gastric acid inhibitors: H2-receptor antagonists (including ranitidine) or proton pump inhibitors (including omeprazole)