Overview

This trial is active, not recruiting.

Conditions short bowel syndrome, necrotizing enterocolitis, small intestine perforation
Treatment microlipid and fish oil
Phase phase 3
Sponsor Wake Forest School of Medicine
Start date October 2009
End date October 2013
Trial size 40 participants
Trial identifier NCT01306838, WFIRB00011501

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
The treatment arm is given early enteral supplementation with MicroLipid and Fish oil.
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.

Primary Outcomes

Measure
Average duration of exposure to PN (including Intralipid, IL) between the initial feeding and bowel reanastomosis
time frame: up to three years

Secondary Outcomes

Measure
Average weight gain (g/day)from initiating feeding to reanastomosis
time frame: up to three years
Average level of conjugated bilirubin and ostomy output of infants receiving ML/FO to the group receiving usual care between the initial feeding after placement of ostomy and reanastomosis
time frame: up to three years
Dietary fat and protein absorption, from initiating feeding to reanastomosis
time frame: up to three years
Expression of four key genes that play a crucial role in intestinal adaptation
time frame: up to four years
Neurodevelopment outcomes and growth in the infants receiving ML/FO vs. in the infants receiving usual care at the 18-24 month of age.
time frame: up to 4.5 years

Eligibility Criteria

Male or female participants up to 60 days old.

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.

Additional Information

Official title Early Supplementation of Enteral Lipid With Combination of Microlipid and Fish Oil in Infants With Enterostomy
Principal investigator Qing Yang, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by Wake Forest School of Medicine.