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

Early Phase 1

Completed

• Conditions: Short Bowel Syndrome; Necrotizing Enterocolitis; Small Intestine Perforation
• Interventions: Dietary Supplement: MicroLipid and fish oil; Other: Routine care

• Registration Number: NCT01306838
• Lead Sponsor: Wake Forest University

Brief 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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2011-03-01
• Study First Submitted QC: 2011-03-01
• Study First Posted: 2011-03-02
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	MicroLipid and fish oil	The treatment arm is given early enteral supplementation with MicroLipid and Fish oil.
Control Group	Routine care	Routine care

Primary Outcome Measures

Name	Time	Method
Average duration of exposure to PN (including Intralipid, IL) between the initial feeding and bowel reanastomosis	up to three years	We hypothesize that the average duration of exposure to PN/IL of the infants receiving ML/FO will be less than that of infants receiving usual care. The ratio of enteral to parenteral nutrition in the infants receiving ML/FO will be greater than that of infants receiving usual care.

Secondary Outcome Measures

Name	Time	Method
Expression of four key genes that play a crucial role in intestinal adaptation	up to four years	RNA expression of four genes in small intestine, peptide YY (PYY), apical sodium dependent bile acid transport (ASBT), glucagon-like peptide-2 (GLP-2), and CD36 or fatty acid translocase (FAT), will be measured in both samples from stoma and distal mucous fistula sites.
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	up to three years	W hypothesize that the average level of conjugated bilirubin and ostomy output of infants receiving ML/FO will be less than that of infants receiving usual care.
Dietary fat and protein absorption, from initiating feeding to reanastomosis	up to three years	Twenty-four hour stool (from ostomy) will be collected once per week after initiating feeding. Fecal fat and protein will be measured. Dietary fat and protein absorption will be calculated by subtracting fecal fat or protein from enteral dietary fat or protein, respectively.; We hypothesize that infants receiving enteral ML/FO will have higher dietary fat and protein absorption than infants receiving routine care from initiating feeding to reanastomosis.
Average weight gain (g/day)from initiating feeding to reanastomosis	up to three years	We hypothesize that the average weight gain in infants receiving ML/FO will be greater than that of infants receiving usual care.
Neurodevelopment outcomes and growth in the infants receiving ML/FO vs. in the infants receiving usual care at the 18-24 month of age.	up to 4.5 years	We hypothesize that the early supplement of enteral ML/FO will have no adverse effect on the neurodevelopment outcomes and growth in the infants receiving ML/FO comparing to the infants receiving usual care at the 18-24 month of age.

Trial Locations

Locations (1)

WFUHS Brenner Children's Hospital NICU; 🇺🇸 Winston-Salem, North Carolina, United States