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

Necrotizing Enterocolitis Clinical Trial

— EMLFO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306838
• Other study ID #: IRB00011501
• Status: Completed
• Phase: Early Phase 1
• Start date: October 2009
• Est. completion date: October 2014

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 60 Days

Eligibility

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.

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Intestinal Perforation
• Necrotizing Enterocolitis
• Short Bowel Syndrome
• Small Intestine Perforation

Intervention

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

Locations

Country	Name	City	State
United States	WFUHS Brenner Children's Hospital NICU	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University

Country where clinical trial is conducted

United States, 

References & Publications (5)

Woods CW, Ayers K, Turner C, Pranikoff T and Yang Q. A Novel Nutritional Approach to Prevent Parenteral Nutrition-Associated Cholestasis in Two Premature Infants with Short Bowel Syndrome. ICAN: Infant, Child, & Adolescent Nutrition 2013 5: 32-36

Yang Q, Ayers K, Chen Y, Helderman J, Welch CD, O'Shea TM. Early enteral fat supplement and fish oil increases fat absorption in the premature infant with an enterostomy. J Pediatr. 2013 Aug;163(2):429-34. doi: 10.1016/j.jpeds.2013.01.056. Epub 2013 Feb 2 — View Citation

Yang Q, Kock ND. Effects of dietary fish oil on intestinal adaptation in 20-day-old weanling rats after massive ileocecal resection. Pediatr Res. 2010 Sep;68(3):183-7. doi: 10.1203/00006450-201011001-00355. — View Citation

Yang Q, Lan T, Chen Y, Dawson PA. Dietary fish oil increases fat absorption and fecal bile acid content without altering bile acid synthesis in 20-d-old weanling rats following massive ileocecal resection. Pediatr Res. 2012 Jul;72(1):38-42. doi: 10.1038/pr.2012.41. Epub 2012 Mar 23. — View Citation

Yang Q, Welch CD, Ayers K, Turner C, Pranikoff T. Early enteral fat supplementation with microlipid® and fish oil in the treatment of two premature infants with short bowel. Neonatology. 2010;98(4):348-53. doi: 10.1159/000316067. Epub 2010 Oct 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average duration of exposure to PN (including Intralipid, IL) between the initial feeding and bowel reanastomosis	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.	up to three years
Secondary	Average weight gain (g/day)from initiating feeding to reanastomosis	We hypothesize that the average weight gain in infants receiving ML/FO will be greater than that of infants receiving usual care.	up to three years
Secondary	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	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.	up to three years
Secondary	Dietary fat and protein absorption, from initiating feeding to reanastomosis	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.	up to three years
Secondary	Expression of four key genes that play a crucial role in intestinal adaptation	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.	up to four years
Secondary	Neurodevelopment outcomes and growth in the infants receiving ML/FO vs. in the infants receiving usual care at the 18-24 month of age.	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.	up to 4.5 years