Clinical Trial: Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies

Brief Summary:

Necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP) are common devastating gastrointestinal diseases in premature infants. These infants often need surgical intervention to remove the dead bowel and create temporary enterostomies, resulting in short bowel syndrome (SBS), a malabsorption state due to insufficient bowel length or dysfunction to digest and absorb nutrients adequately.

These infants are often nourished primarily with parental nutrition (PN) which can lead to many complications including PN-associated liver disease. However, with enteral feeding, the remaining bowel can adapt somewhat to the shortened state, reducing the need for PN. Enteral fats appear to be the most trophic macronutrients with the long chain polyunsaturated fatty acids (LCPUFA) being the most beneficial in promoting bowel adaptation.

Fish oil (FO), a main source of n-3 LCPUFA, has been shown to promote bowel adaptation. Microlipid (ML) primarily contains n-6 PUFA and has been found to decrease ostomy output and increase weight gain in some SBS infants. WThe investigators will soon have completed a randomized clinical trial (EMLFO trial) (WFUHS IRB00011501, NCT01306838) entitled "Early Supplementation of Enteral Lipid with Combination of Microlipid and Fish Oil in Infants with Enterostomies". The preliminary data suggest that (a) by supplementing enteral ML/FO, we were able to decrease the use of IL; (b) premature infants in the treatment group who received ML/FO achieved higher enteral calorie (% of total calorie) intake before reanastomosis and better weight gain (g/day) after reanastomosis than those who received routine care in control group; and (c) the direct bilirubin level before reanastomosis tended to be lower in the treatment group than the control group although the difference was not statisticall

Detailed Summary: In comparison to EMLFO trial, the EMLFO-2 study will modify the eligibility criteria to only enroll the infants who have birthweight equal to or less than 1250 g with a jejunostomy or ileostomy as the result of surgical treatment for small intestine perforation or NEC in order to increase the homogeneity of patient population.
Sponsor: Wake Forest University

Current Primary Outcome: The serum biomarkers of oxidative stress and inflammatory cytokines [ Time Frame: 3 years ]

Compare the serum biomarkers of oxidative stress and inflammatory cytokines of the infants receiving ML/FO to the infants only receiving ML between the initial feeding after placement of an ostomy and reanastomosis


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The average enteral calorie (% of total calorie) intake before reanast [ Time Frame: 3 years ]
    To compare the average enteral calorie (% of total calorie) intake of infants receiving ML/FO to the group only receiving ML between the initial feeding after placement of an ostomy and reanastomosis
  • The average weight gain (g/day) after reanastomosis [ Time Frame: 3 years ]
    To compare the the average weight gain (g/day) of infants receiving ML/FO to the infants only receiving ML after reanastomosis


Original Secondary Outcome: Same as current

Information By: Wake Forest University Health Sciences

Dates:
Date Received: August 18, 2012
Date Started: October 2012
Date Completion:
Last Updated: March 17, 2017
Last Verified: March 2017