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

NCT01306838 | Completed Early Phase 1 FDA Drug

• 1 other identifier: IRB00011501
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Short Bowel Syndrome; Necrotizing Enterocolitis; Small Intestine Perforation

Keywords

Short bowel syndrome; Necrotizing enterocolitis; Small intestine perforation; Enterostomy; Intralipid; Microlipid; Fish oil

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Average weight gain (g/day)from initiating feeding to reanastomosis

  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

  up to three years

• Dietary fat and protein absorption, from initiating feeding to reanastomosis

  up to three years

• Expression of four key genes that play a crucial role in intestinal adaptation

  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.

  up to 4.5 years

Study Arms (2)

Treatment

EXPERIMENTAL

The treatment arm is given early enteral supplementation with MicroLipid and Fish oil.

Dietary Supplement: MicroLipid and fish oil

Control Group

ACTIVE COMPARATOR

Routine care

Other: Routine care

Interventions

MicroLipid and fish oil DIETARY_SUPPLEMENT

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.

Treatment

Routine care OTHER

Routine care

Control Group

Eligibility Criteria

• Age: 1 Day - 60 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

WFUHS Brenner Children's Hospital NICU

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (7)

• 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 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

  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

• Younge N, Yang Q, Seed PC. Enteral High Fat-Polyunsaturated Fatty Acid Blend Alters the Pathogen Composition of the Intestinal Microbiome in Premature Infants with an Enterostomy. J Pediatr. 2017 Feb;181:93-101.e6. doi: 10.1016/j.jpeds.2016.10.053. Epub 2016 Nov 15.

  PMID: 27856001 DERIVED

• Yang Q, Ayers K, Chen Y, O'Shea TM. Early enteral fat supplementation improves protein absorption in premature infants with an enterostomy. Neonatology. 2014;106(1):10-6. doi: 10.1159/000357554. Epub 2014 Mar 6.

  PMID: 24603562 DERIVED

MeSH Terms

Conditions

Short Bowel Syndrome; Enterocolitis, Necrotizing

Interventions

Safflower Oil; Fish Oils

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Enterocolitis; Gastroenteritis

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

Study Officials

• Qing Yang, MD, PhD

  Wake Forest Univeristy Health Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2011
• First Posted: March 2, 2011
• Study Start: October 1, 2009
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 15, 2018

Record last verified: 2018-08

Locations

US (1)