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

NCT ID: NCT01306838

Last Updated: 2018-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2014-10-31

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.

Conditions

Short Bowel Syndrome; Necrotizing Enterocolitis; Small Intestine Perforation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

MicroLipid and fish oil

Intervention Type: 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.

Control Group

Routine care

Group Type: ACTIVE_COMPARATOR

Routine care

Intervention Type: OTHER

Routine care

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Routine care

Routine care

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 60 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qing Yang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Univeristy Health Science

Locations

WFUHS Brenner Children's Hospital NICU

Winston-Salem, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20531250 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22447320 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20980771 (View on PubMed)

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

Reference Type: 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.

Reference Type: RESULT

PMID: 23453547 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27856001 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24603562 (View on PubMed)

Other Identifiers

IRB00011501

Identifier Type: -

Identifier Source: org_study_id