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NCT Number: NCT01306838

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

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.

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Key information

Conditions

Short Bowel Syndrome Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Necrotizing Enterocolitis Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Small Intestine Perforation

Age range

1 day–60 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

WFUHS Brenner Children's Hospital NICU

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Routine care

Other

Routine care

Primary outcomes

  1. Average duration of exposure to PN (including Intralipid, IL) between the initial feeding and bowel reanastomosis

    Time frame: up to three years

    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 outcomes

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

    Time frame: up to three years

    We hypothesize that the average weight gain in infants receiving ML/FO will be greater than that of infants receiving usual care.

  2. 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

    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.

  3. Dietary fat and protein absorption, from initiating feeding to reanastomosis

    Time frame: up to three years

    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.

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

    Time frame: up to four years

    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.

  5. 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

    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.

Sponsors and collaborators

Lead sponsor

Wake Forest University

Other

Registry information

Official study title

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

Acronym: EMLFO

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Mar 2, 2011
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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