2.1. Study Design and Subgroup
inflammatory bowel syndrome, birth defect, congenital heart disease
NECROTIZING ENTEROCOLITIS, SHORT BOWEL SYNDROME, SECONDARY, HIRSCHSPRUNG DISEASE, CHROMOSOMAL ABERRATION, DISEASES
This is a secondary analysis of nutritional data collected during a prospective, randomized, two arm intervention trial and the association with neurodevelopmental outcome in infants born with a birth weight <1500 g. The initial study was designed to investigate the introduction of CF in VLBW infants at two different timepoints. Infants were either introduced to solids between the 10th and 12th week CA (early group) or between the 16th and 18th week CA (late group) and fed a standardized feeding concept throughout the first year CA. Exclusion criteria were any diseases that might affect stable growth (e.g., Hirschsprung disease, inflammatory bowel syndrome, necrotizing enterocolitis with short bowel syndrome, any chromosomal aberration, congenital heart disease, major congenital birth defect). The study was conducted from October 2013 until February 2020 in the outpatient clinic of the Division of Neonatology, Department of Pediatrics, Medical University of Vienna and approved by the ethics committee of the Medical University of Vienna (EK: 1744/2012). The detailed study design was described previously [