NCT01306838

Early Provision of Enteral Microlipid and Fish Oil to Infants With Enterostomy

Early Supplementation of Enteral Lipid With Combination of Microlipid and Fish Oil in Infants With Enterostomy

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Wake Forest University · Academic / Other
• Sex: All
• Age: 1 Day – 60 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Short Bowel Syndrome
• Necrotizing Enterocolitis
• Small Intestine Perforation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	MicroLipid and fish oil	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.
OTHER	Routine care	Routine care

Timeline

• Start date: 2009-10-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2011-03-02
• Last updated: 2018-08-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study