Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies
Condition: Prematurity; Intestine Perforation; Necrotizing Enterocolitis (NEC); Short Bowel Syndrome (SBS)
MeSH terms: Enterocolitis; Enterocolitis, Necrotizing; Short Bowel Syndrome; Intestinal Perforation
Intervention: Microlipid with fish oil; Microlipid
Intervention description: Fish oil will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which both will be continued until reanastomosis.; A small amount (ml) of Microlipid to match the amount of fish oil in ML/FO group will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which will be continued until reanastomosis.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 1 Day
Maximum age: 2 Months
Healthy volunteers: No
Keywords: NEC, SBS, enterostomy, fish oil, Microlipid, Intralipid,; enteral fat

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 statistically
      significant. Because the intervention consisted of both an increase in enteral fat intake as
      well as a specific type of fat intake (i.e. FO), it is unclear whether improved outcomes in
      the ML/FO group are attributable to FO's anti-inflammatory effects or the increased fat
      intake. Therefore, the investigators have designed a next randomized clinical trial to
      compare ML alone versus ML plus FO. We hypothesize that as compared to ML alone, ML plus FO
      will result in decreased systemic inflammation, as indicated by blood levels of
      inflammation-related proteins and indicators of oxidative stress.
    

Eligibility criteria:

        Inclusion Criteria:

          1. infants (age range: newborn to ≤ 2-month-old) whose birth weight are ≤ 1250g;

          2. who are admitted to BCH NICU for surgical intervention for NEC or small intestine
             perforation and then to have a jejunostomy or ileostomy;

          3. who are expected to need full or partial PN for at least 21days from the day of ostomy
             placement; and

          4. who have received enteral feedings ≤ 4 days since ostomy placement.

        Exclusion Criteria:

          1. infant with birth weight > 1250g;

          2. infant with colostomy;

          3. infants with enterostomy but

               -  unable to obtain written informed consent from parent;

               -  presence of congenital liver, renal, or metabolic diseases or syndromes or
                  perinatal asphyxia;

               -  ostomy caused by surgical treatment for a condition other than NEC or small
                  intestine perforation; and

               -  unable to initiate enteral feeding for more than 28 days since ostomy placement.