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

Wake Forest University (WFU)

Status and phase

Completed

Early Phase 1

Conditions

Short Bowel Syndrome

Necrotizing Enterocolitis

Small Intestine Perforation

Treatments

Other: Routine care

Dietary Supplement: MicroLipid and fish oil

Study type

Interventional

Funder types

Other

Identifiers

NCT01306838

IRB00011501

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

1 to 60 days old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.