Early Provision of Enteral Microlipid and Fish Oil to Infants With Enterostomy
Condition: Short Bowel Syndrome; Necrotizing Enterocolitis; Small Intestine Perforation
MeSH terms: Enterocolitis; Enterocolitis, Necrotizing; Short Bowel Syndrome; Intestinal Perforation
Study type: Interventional
Phase: Early Phase 1

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 description: 
      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.
    

Intervention name(s): MicroLipid and fish oil; Routine care
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Infants in treatment arm will receive the same nutrition support as control group before they tolerate enteral feeding at 20 ml/kg/day. Then they will receive study oils when feeds reach 30 ml/kg/day.; Routine care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Short bowel syndrome; Necrotizing enterocolitis; Small intestine perforation; Enterostomy; Intralipid; Microlipid; Fish oil