Early Provision of Enteral Microlipid and Fish Oil to Infants With Enterostomy
Completed · Early Phase 1
Conditions studied: Short Bowel Syndrome, Necrotizing Enterocolitis, Small Intestine Perforation
In brief
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.
Key facts
- Study ID
- NCT01306838
- Run by
- Wake Forest University
- People needed
- 40
- Starts
- 2009-10-01
- Expected to finish
- 2014-10-01
- Last updated by the study team
- 2018-08-15
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- infants (age range: newborn to 2-month-old) who are admitted to BCH NICU with a jejunostomy or ileostomy (from surgical intervention for NEC, bowel perforation, midgut volvulus (twisted bowel), atresia or other gastrointestinal surgery);
- who are expected to need full or partial PN for at least 21days from the day of enterostomy placement; and
- have received enteral feedings ≤ 4 days since enterostomy placement
You may not qualify if…
- infant with colostomy;
- infants with enterostomy but
- unable to obtain written informed consent from parent;
- presence of congenital liver or renal, or metabolic diseases; and
- ostomy caused by gastroschisis, omphalocele, imperforate anus, and perinatal asphyxia
- unable to initiate enteral feeds after 28 days of ostomy placement.
Where it is running
- WFUHS Brenner Children's Hospital NICU — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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