Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies

NCT01674478 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB00021481
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP) are common devastating gastrointestinal diseases in premature infants. These infants often need surgical intervention to remove the dead bowel and create temporary enterostomies, resulting in short bowel syndrome (SBS), a malabsorption state due to insufficient bowel length or dysfunction to digest and absorb nutrients adequately. These infants are often nourished primarily with parental nutrition (PN) which can lead to many complications including PN-associated liver disease. However, with enteral feeding, the remaining bowel can adapt somewhat to the shortened state, reducing the need for PN. Enteral fats appear to be the most trophic macronutrients with the long chain polyunsaturated fatty acids (LCPUFA) being the most beneficial in promoting bowel adaptation. Fish oil (FO), a main source of n-3 LCPUFA, has been shown to promote bowel adaptation. Microlipid (ML) primarily contains n-6 PUFA and has been found to decrease ostomy output and increase weight gain in some SBS infants. WThe investigators will soon have completed a randomized clinical trial (EMLFO trial) (WFUHS IRB00011501, NCT01306838) entitled "Early Supplementation of Enteral Lipid with Combination of Microlipid and Fish Oil in Infants with Enterostomies". The preliminary data suggest that (a) by supplementing enteral ML/FO, we were able to decrease the use of IL; (b) premature infants in the treatment group who received ML/FO achieved higher enteral calorie (% of total calorie) intake before reanastomosis and better weight gain (g/day) after reanastomosis than those who received routine care in control group; and (c) the direct bilirubin level before reanastomosis tended to be lower in the treatment group than the control group although the difference was not statistically significant. Because the intervention consisted of both an increase in enteral fat intake as well as a specific type of fat intake (i.e. FO), it is unclear whether improved outcomes in the ML/FO group are attributable to FO's anti-inflammatory effects or the increased fat intake. Therefore, the investigators have designed a next randomized clinical trial to compare ML alone versus ML plus FO. We hypothesize that as compared to ML alone, ML plus FO will result in decreased systemic inflammation, as indicated by blood levels of inflammation-related proteins and indicators of oxidative stress.

Conditions

Prematurity; Intestine Perforation; Necrotizing Enterocolitis (NEC); Short Bowel Syndrome (SBS)

Keywords

NEC, SBS, enterostomy, fish oil, Microlipid, Intralipid,; enteral fat

Outcome Measures

Primary Outcomes (2)

• The Serum Biomarkers of Inflammatory Cytokines

  Compare the serum biomarkers of inflammatory cytokines of the infants receiving ML/FO to the infants only receiving ML between the initial feeding after placement of an ostomy and reanastomosis

  2 years and 5 months

• The Serum Biomarkers of Oxidative Stress

  Compare the serum biomarkers of oxidative stress of the infants receiving ML/FO to the infants only receiving ML between the initial feeding after placement of an ostomy and reanastomosis

  2 years and 5 months

Secondary Outcomes (2)

• The Average Enteral Calorie (Total Calorie) Intake Before Reanast

  2 years and 5 months

• The Average Weight Gain (g/Day) After Reanastomosis

  2 years and 5 months

Study Arms (2)

Microlipid with fish oil group

EXPERIMENTAL

This group will be given early enteral lipid supplementation with Microlipid and fish oil.

Dietary Supplement: Microlipid with fish oil

Microlipid group

ACTIVE COMPARATOR

This group will be given early enteral lipid supplementation only with Microlipid.

Dietary Supplement: Microlipid

Interventions

Microlipid with fish oil DIETARY_SUPPLEMENT

Fish oil will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which both will be continued until reanastomosis.

Microlipid with fish oil group

Microlipid DIETARY_SUPPLEMENT

A small amount (ml) of Microlipid to match the amount of fish oil in ML/FO group will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which will be continued until reanastomosis.

Microlipid group

Eligibility Criteria

• Age: 1 Day - 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• infants (age range: newborn to ≤ 2-month-old) whose birth weight are ≤ 1250g;
• who are admitted to BCH NICU for surgical intervention for NEC or small intestine perforation and then to have a jejunostomy or ileostomy;
• who are expected to need full or partial PN for at least 21days from the day of ostomy placement; and
• who have received enteral feedings ≤ 4 days since ostomy placement.

You may not qualify if:

• infant with birth weight \> 1250g;
• infant with colostomy;
• infants with enterostomy but
• unable to obtain written informed consent from parent;
• presence of congenital liver, renal, or metabolic diseases or syndromes or perinatal asphyxia;
• ostomy caused by surgical treatment for a condition other than NEC or small intestine perforation; and
• unable to initiate enteral feeding for more than 28 days since ostomy placement.

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest University Health Science

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (5)

• 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/PDR.0b013e3181eb2ee5.

  PMID: 20531250 BACKGROUND

• 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.

  PMID: 22447320 BACKGROUND

• Yang Q, Welch CD, Ayers K, Turner C, Pranikoff T. Early enteral fat supplementation with microlipid(R) 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.

  PMID: 20980771 RESULT

• Woods CW, Ayers K, Turner C, Pranikoff T and Qing Yang. 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.

  RESULT

• 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 28.

  PMID: 23453547 RESULT

MeSH Terms

Conditions

Premature Birth; Intestinal Perforation; Enterocolitis, Necrotizing; Short Bowel Syndrome

Interventions

Safflower Oil; Fish Oils

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Enterocolitis; Gastroenteritis; Malabsorption Syndromes; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Dr. Qing Yang
• Organization: Wake Forest University Health Sciences

qyang@wakehealth.edu

Study Officials

• Qing Yang, MD, PhD

  WFUHS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2012
• First Posted: August 28, 2012
• Study Start: October 1, 2012
• Primary Completion: March 17, 2015
• Study Completion: March 17, 2015
• Last Updated: December 4, 2018
• Results First Posted: December 4, 2018

Record last verified: 2018-11

Locations

US (1)