title: Intestinal mucosa remodeling by recombinant human epidermal growth factor(1-48) in neonates with severe necrotizing enterocolitis.
abstract: OBJECTIVE
  Neonatal 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 (EGF(1-48)) in neonates with NEC.
  
  
  METHODS
  This prospective, double-blind, randomized controlled study included 8 neonates with NEC. The study compared the effects of a 6-day continuous intravenous infusion of EGF(1-48) 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.
  
  
  RESULTS
  There was no difference between the clinical safety outcomes recorded for EGF(1-48) or placebo patients. Quantitative morphologic differences in the rectal mucosa biopsies were noted with EGF(1-48) 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.
  
  
  CONCLUSIONS
  This study of EGF(1-48) 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.
authors.affiliation: Department of Paediatrics, University of Oxford, John Radcliffe Hospital, Oxford OX3 9DU, UK. peter.sullivan@paediatrics.ox.ac.uk
authors.forename: Peter B
authors.initials: PB
authors.lastname: Sullivan
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Lewindon
authors.forename: Carmen
authors.initials: C
authors.lastname: Cheng
authors.forename: Peter F
authors.initials: PF
authors.lastname: Lenehan
authors.forename: Bo-Sheng
authors.initials: BS
authors.lastname: Kuo
authors.forename: Jeffrey R
authors.initials: JR
authors.lastname: Haskins
authors.forename: Robert A
authors.initials: RA
authors.lastname: Goodlad
authors.forename: Nicholas A
authors.initials: NA
authors.lastname: Wright
authors.forename: Felix A
authors.initials: FA
authors.lastname: de la Iglesia
authors.forename: Felix A
authors.initials: FA
authors.lastname: dela Iglesia
mesh_terms: D004311:Double-Blind Method; D020345:Enterocolitis, Necrotizing / Q000188:drug therapy* / Q000503:physiopathology; D004815:Epidermal Growth Factor / Q000494:pharmacology* / Q000627:therapeutic use; D005260:Female; D005765:Gastrointestinal Agents / Q000494:pharmacology* / Q000627:therapeutic use; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007413:Intestinal Mucosa / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D010446:Peptide Fragments / Q000494:pharmacology* / Q000627:therapeutic use; D011446:Prospective Studies
chemical_list: D005765:Gastrointestinal Agents; D010446:Peptide Fragments; C102344:epidermal growth factor (1-48); D004815:Epidermal Growth Factor