Necrotizing Enterocolitis Clinical Trial
Official title:
Early Supplementation of Enteral Lipid With Combination of Microlipid and Fish Oil in Infants With Enterostomy
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.
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.
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