Prematurity Clinical Trial
Official title:
Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies
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.
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. ;
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