Clinical Trial: Early Provision of Enteral Microlipid and Fish Oil to Infants With Enterostomy

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

Official Title: Early Supplementation of Enteral Lipid With Combination of Microlipid and Fish Oil in Infants With Enterostomy

Brief Summary:

Necrotizing enterocolitis (NEC) and intestinal perforation are common in premature infants. Often surgery is needed to remove the dead bowel and create an ostomy (a temporary intestinal opening on the infant's abdomen). Infants with ostomies cannot digest and absorb food well, and must receive nutrition through the blood stream, i.e. parental nutrition (PN). However, prolonged dependence on PN can severely damage the liver and gut. Therefore, giving nutrition through the gut, i.e. enteral nutrition, is the primary treatment for infants with ostomies.

Enteral fats, especially polyunsaturated fatty acids (PUFA), are most beneficial in stimulating gut mucosal adaptation, which begins 24 to 48 hours following bowel resection. In addition, the premature intestine has a rapid growth rate. It is likely that the current clinical practice of giving a relatively low-fat diet to infants with ostomies may not meet their high metabolic needs.

The investigators hypothesize that increasing dietary fat content by early supplementation with MicroLipid® (ML, n-6 PUFA) and fish oil (FO, n-3 PUFA) to preserve the proper balance of n-6 and n-3 PUFA, may (i) improve bowel adaptation and infant growth; (ii) reduce the use of PN; and (iii) prevent liver damage and/or cholestasis (jaundice) in infants with ostomies.

Detailed Summary:

It is an interventional randomized open-labeled controlled trial with two groups:

Treatment group: early supplementation of enteral lipid with ML and FO; Control group: routine care.

The primary goal of this study is to obtain pilot data that will inform the subsequent design and execution of a large, randomized trial which will test the hypothesis that infants with short bowel syndrome or ostomy will experience beneficial growth effects from enteral nutrition supplemented with balanced n6/n-3 PUFA, a simple, inexpensive and noninvasive intervention. This pilot study will confirm the safety of PUFA supplemented enteral nutrition, establish the length and amount of enteral versus parenteral nutrition required, and determine the impact on infant growth and intestinal adaptation by measuring expression of four key genes that play a crucial role in intestinal adaptation.

Sponsor: Wake Forest University

Current Primary Outcome: Average duration of exposure to PN (including Intralipid, IL) between the initial feeding and bowel reanastomosis [ Time Frame: up to three years ]

Original Primary Outcome: Average daily weight gain between the initial feeding and bowel reanastomosis [ Time Frame: up to three years ]

Current Secondary Outcome:

• Average weight gain (g/day)from initiating feeding to reanastomosis [ Time Frame: up to three years ]
  We hypothesize that the average weight gain in infants receiving ML/FO will be greater than that of infants receiving usual care.
• Average level of conjugated bilirubin and ostomy output of infants receiving ML/FO to the group receiving usual care between the initial feeding after placement of ostomy and reanastomosis [ Time Frame: up to three years ]
  W hypothesize that the average level of conjugated bilirubin and ostomy output of infants receiving ML/FO will be less than that of infants receiving usual care.
• Dietary fat and protein absorption, from initiating feeding to reanastomosis [ Time Frame: up to three years ]

  Twenty-four hour stool (from ostomy) will be collected once per week after initiating feeding. Fecal fat and protein will be measured. Dietary fat and protein absorption will be calculated by subtracting fecal fat or protein from enteral dietary fat or protein, respectively.

  We hypothesize that infants receiving enteral ML/FO will have higher dietary fat and protein absorption than infants receiving routine care from initiating feeding to reanastomosis.

• Expression of four key genes that play a crucial role in intestinal adaptation [ Time Frame: up to four years ]
  RNA expression of four genes in small intestine, peptide YY (PYY), apical sodium dependent bile acid transport (ASBT), glucagon-like peptide-2 (GLP-2), and CD36 or fatty acid translocase (FAT), will be measured in both samples from stoma and distal mucous fistula sites.
• Neurodevelopment outcomes and growth in the infants receiving ML/FO vs. in the infants receiving usual care at the 18-24 month of age. [ Time Frame: up to 4.5 years ]
  We hypothesize that the early supplement of enteral ML/FO will have no adverse effect on the neurodevelopment outcomes and growth in the infants receiving ML/FO comparing to the infants receiving usual care at the 18-24 month of age.

Original Secondary Outcome:

• Days of using PN including IL, from initiating feeding to reanastomosis [ Time Frame: up to three years ]
• Ratio of EN to PN, from initiating feeding to reanastomosis [ Time Frame: up to three years ]
• Ostomy output, from initiating feeding to reanastomosis [ Time Frame: up to three years ]
• Abnormal level of conjugated bilirubin (> 2 mg/dl) before and after reanastomosis [ Time Frame: up to three years ]
• Dietary fat absorption, from initiating feeding to reanastomosis [ Time Frame: up to three years ]
  Twenty-four hour stool (from ostomy) will be collected once per week after initiating feeding. Fecal fat will be extracted. Dietary fat absorption will be calculated by subtracting fecal fat from enteral dietary fat.
• Expression of four key genes that play a crucial role in intestinal adaptation [ Time Frame: up to three years ]
  RNA expression of four genes in small intestine, peptide YY (PYY), apical sodium dependent bile acid transport (ASBT), glucagon-like peptide-2 (GLP-2), and CD36 or fatty acid translocase (FAT), will be measured in both samples from stoma and distal mucous fistula sites.

Information By: Wake Forest University Health Sciences

Dates:
Date Received: March 1, 2011
Date Started: October 2009
Date Completion:
Last Updated: March 17, 2017
Last Verified: March 2017