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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Qing Yang, Wake Forest University
ClinicalTrials.gov Identifier:
NCT01306838
First received: March 1, 2011
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Short Bowel Syndrome
Necrotizing Enterocolitis
Small Intestine Perforation
Dietary Supplement: MicroLipid and fish oil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Early Supplementation of Enteral Lipid With Combination of Microlipid and Fish Oil in Infants With Enterostomy

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Average duration of exposure to PN (including Intralipid, IL) between the initial feeding and bowel reanastomosis [ Time Frame: up to three years ] [ Designated as safety issue: No ]
    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:
  • Average weight gain (g/day)from initiating feeding to reanastomosis [ Time Frame: up to three years ] [ Designated as safety issue: No ]
    We hypothesize that the average weight gain in infants receiving ML/FO will be greater than that of infants receiving usual care.

  • 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 [ Time Frame: up to three years ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to three years ] [ Designated as safety issue: No ]

    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.


  • Expression of four key genes that play a crucial role in intestinal adaptation [ Time Frame: up to four years ] [ Designated as safety issue: No ]
    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.

  • Neurodevelopment outcomes and growth in the infants receiving ML/FO vs. in the infants receiving usual care at the 18-24 month of age. [ Time Frame: up to 4.5 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: October 2009
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
The treatment arm is given early enteral supplementation with MicroLipid and Fish oil.
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.

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.

  Eligibility

Ages Eligible for Study:   up to 60 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01306838

Locations
United States, North Carolina
WFUHS Brenner Children's Hospital NICU
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Qing Yang, MD, PhD Wake Forest Univeristy Health Science
  More Information

Publications:
Responsible Party: Qing Yang, Associate Proferssor of Pediatrics, Wake Forest University
ClinicalTrials.gov Identifier: NCT01306838     History of Changes
Other Study ID Numbers: WFIRB00011501
Study First Received: March 1, 2011
Last Updated: May 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Short bowel syndrome
Necrotizing enterocolitis
Small intestine perforation
Enterostomy
Intralipid
Microlipid
Fish oil

Additional relevant MeSH terms:
Enterocolitis
Enterocolitis, Necrotizing
Intestinal Perforation
Short Bowel Syndrome
Syndrome
Digestive System Diseases
Disease
Gastroenteritis
Gastrointestinal Diseases
Intestinal Diseases
Malabsorption Syndromes
Pathologic Processes
Postoperative Complications

ClinicalTrials.gov processed this record on November 20, 2014