title: Randomized Clinical Trial of Preoperative Feeding to Evaluate Intestinal Barrier Function in Neonates Requiring Cardiac Surgery.
abstract: OBJECTIVE
  To evaluate intestinal barrier function in neonates undergoing cardiac surgery using lactulose/mannitol (L/M) ratio measurements, and to determine correlations with early breast milk feeding.
  
  
  METHODS
  This was a single-center, prospective, randomized pilot study of 27 term-born neonates (≥ 37 weeks gestation) requiring cardiac surgery who were randomized to 1 of 2 preoperative feeding groups: nil per os (NPO) or trophic (10 mL/kg/day) breast milk feeds. At 3 time points (preoperative [preop], postoperative [postop] day 7, and postop day 14), subjects were administered an oral L/M solution, after which urine L/M ratios were measured using gas chromatography, with higher ratios indicative of increased intestinal permeability. Trends over time in the mean urine L/M ratios for each group were estimated using a general linear mixed model.
  
  
  RESULTS
  There were no adverse events related to preoperative trophic feeding. In the NPO group (n = 13), the mean urine L/M ratio was 0.06 at preop, 0.12 at postop day 7, and 0.17 at postop day 14. In the trophic breast milk feeds group (n = 14), the mean urine L/M ratio was 0.09 at preop, 0.19 at postop day 7, and 0.15 at postop day 14. In both groups, L/M ratios were significantly higher at postop day 7 and postop day 14 compared with preop (P < .05).
  
  
  CONCLUSIONS
  Neonates have increased intestinal permeability after cardiac surgery extending to at least postop day 14. This pilot study was not powered to detect differences in benefit or adverse events comparing the NPO and trophic breast milk feeds groups. Further studies to identify mechanisms of intestinal injury and therapeutic interventions are warranted.
  
  
  BACKGROUND
  Registered with ClinicalTrials.gov: NCT01475357.
authors.affiliation: Division of Pediatric Cardiology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC. Electronic address: chois@musc.edu.
authors.forename: Sinai C
authors.initials: SC
authors.lastname: Zyblewski
authors.affiliation: Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Nietert
authors.affiliation: Division of Pediatric Cardiology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC.
authors.forename: Eric M
authors.initials: EM
authors.lastname: Graham
authors.affiliation: Division of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC.
authors.forename: Sarah N
authors.initials: SN
authors.lastname: Taylor
authors.affiliation: Division of Pediatric Cardiology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC.
authors.forename: Andrew M
authors.initials: AM
authors.lastname: Atz
authors.affiliation: Division of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC.
authors.forename: Carol L
authors.initials: CL
authors.lastname: Wagner
mesh_terms: D015415:Biomarkers / Q000652:urine; D006348:Cardiac Surgical Procedures; D004750:Enteral Nutrition; D020345:Enterocolitis, Necrotizing / Q000175:diagnosis; D005260:Female; D006801:Humans; D041943:Infant Formula / Q000008:administration & dosage*; D007231:Infant, Newborn; D007413:Intestinal Mucosa / Q000378:metabolism*; D007792:Lactulose / Q000493:pharmacokinetics* / Q000652:urine; D008297:Male; D008353:Mannitol / Q000493:pharmacokinetics* / Q000652:urine; D008895:Milk, Human; D010539:Permeability; D010865:Pilot Projects; D011300:Preoperative Care; D011446:Prospective Studies
chemical_list: D015415:Biomarkers; D008353:Mannitol; D007792:Lactulose