Intestinal mucosa remodeling by recombinant human epidermal growth factor1-48 in neonates with severe necrotizing enterocolitis

Background and AimsNeonatal necrotizing enterocolitis (NEC) is a common and serious acquired gastrointestinal tract condition. This clinical study assessed the potential clinical efficacy and microscopic effects of recombinant human epidermal growth factor 1-48 (EGF1-48) in neonates with NEC.MethodsThis prospective, double-blind, randomized controlled study included 8 neonates with NEC. The study compared the effects of a 6-day continuous intravenous infusion of EGF1-48 at 100 ng kg−1 h−1 against placebo. Clinical outcomes and morphological evaluation of serial rectal mucosal biopsies were assessed at baseline and 4, 7, and 14 days after starting EGF infusions.ResultsThere was no difference between the clinical safety outcomes recorded for EGF1-48 or placebo patients. Quantitative morphologic differences in the rectal mucosa biopsies were noted with EGF1-48 treatment compared with baseline or placebo and included a statistically significant increase in the number of mitoses per mucosal crypt on study day 4, significantly increased thickness of rectal mucosa from baseline on study days 4 and 7, and increased crypt surface area of rectal mucosa in parallel with increased mucosa thickness on day 14.ConclusionThis study of EGF1-48 in neonates with severe NEC showed that growth factor treatment was well tolerated and produced positive and measurable remodeling trophic effects on the gastrointestinal mucosa.