Early Provision of Enteral Microlipid and Fish Oil to Infants With Enterostomy (EMLFO)
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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 |
- Average daily weight gain between the initial feeding and bowel reanastomosis [ Time Frame: up to three years ] [ Designated as safety issue: No ]
- Days of using PN including IL, from initiating feeding to reanastomosis [ Time Frame: up to three years ] [ Designated as safety issue: No ]
- Ratio of EN to PN, from initiating feeding to reanastomosis [ Time Frame: up to three years ] [ Designated as safety issue: No ]
- Ostomy output, from initiating feeding to reanastomosis [ Time Frame: up to three years ] [ Designated as safety issue: Yes ]
- Abnormal level of conjugated bilirubin (> 2 mg/dl) before and after reanastomosis [ Time Frame: up to three years ] [ Designated as safety issue: No ]
- Dietary fat 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 will be extracted. Dietary fat absorption will be calculated by subtracting fecal fat from enteral dietary fat.
- Expression of four key genes that play a crucial role in intestinal adaptation [ Time Frame: up to three 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.
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | June 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 |
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
Contacts and Locations| United States, North Carolina | |
| WFUHS Brenner Children's Hospital NICU | |
| Winston Salem, North Carolina, United States, 27157 | |
| Principal Investigator: | Qing Yang, MD, PhD | Wake Forest Univeristy Health Science |
More Information
No publications provided
| 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: | August 22, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Wake Forest University:
|
Short bowel syndrome Necrotizing enterocolitis Small intestine perforation Enterostomy |
Intralipid Microlipid Fish oil |
Additional relevant MeSH terms:
|
Enterocolitis Intestinal Perforation Short Bowel Syndrome Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Intestinal Diseases Malabsorption Syndromes Postoperative Complications Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013