Trial record 14 of 30 for:    Open Studies | "Malabsorption Syndromes" | United States

Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies (EMLFO-2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Wake Forest School of Medicine
Sponsor:
Information provided by (Responsible Party):
Qing Yang, Wake Forest University
ClinicalTrials.gov Identifier:
NCT01674478
First received: August 18, 2012
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

Necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP) are common devastating gastrointestinal diseases in premature infants. These infants often need surgical intervention to remove the dead bowel and create temporary enterostomies, resulting in short bowel syndrome (SBS), a malabsorption state due to insufficient bowel length or dysfunction to digest and absorb nutrients adequately.

These infants are often nourished primarily with parental nutrition (PN) which can lead to many complications including PN-associated liver disease. However, with enteral feeding, the remaining bowel can adapt somewhat to the shortened state, reducing the need for PN. Enteral fats appear to be the most trophic macronutrients with the long chain polyunsaturated fatty acids (LCPUFA) being the most beneficial in promoting bowel adaptation.

Fish oil (FO), a main source of n-3 LCPUFA, has been shown to promote bowel adaptation. Microlipid (ML) primarily contains n-6 PUFA and has been found to decrease ostomy output and increase weight gain in some SBS infants. WThe investigators will soon have completed a randomized clinical trial (EMLFO trial) (WFUHS IRB00011501, NCT01306838) entitled "Early Supplementation of Enteral Lipid with Combination of Microlipid and Fish Oil in Infants with Enterostomies". The preliminary data suggest that (a) by supplementing enteral ML/FO, we were able to decrease the use of IL; (b) premature infants in the treatment group who received ML/FO achieved higher enteral calorie (% of total calorie) intake before reanastomosis and better weight gain (g/day) after reanastomosis than those who received routine care in control group; and (c) the direct bilirubin level before reanastomosis tended to be lower in the treatment group than the control group although the difference was not statistically significant. Because the intervention consisted of both an increase in enteral fat intake as well as a specific type of fat intake (i.e. FO), it is unclear whether improved outcomes in the ML/FO group are attributable to FO's anti-inflammatory effects or the increased fat intake. Therefore, the investigators have designed a next randomized clinical trial to compare ML alone versus ML plus FO. We hypothesize that as compared to ML alone, ML plus FO will result in decreased systemic inflammation, as indicated by blood levels of inflammation-related proteins and indicators of oxidative stress.


Condition Intervention
Prematurity
Intestine Perforation
Necrotizing Enterocolitis (NEC)
Short Bowel Syndrome (SBS)
Dietary Supplement: Microlipid and fish oil
Dietary Supplement: Microlipid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The serum biomarkers of oxidative stress and inflammatory cytokines [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Compare the serum biomarkers of oxidative stress and inflammatory cytokines of the infants receiving ML/FO to the infants only receiving ML between the initial feeding after placement of an ostomy and reanastomosis


Secondary Outcome Measures:
  • The average enteral calorie (% of total calorie) intake before reanast [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    To compare the average enteral calorie (% of total calorie) intake of infants receiving ML/FO to the group only receiving ML between the initial feeding after placement of an ostomy and reanastomosis

  • The average weight gain (g/day) after reanastomosis [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    To compare the the average weight gain (g/day) of infants receiving ML/FO to the infants only receiving ML after reanastomosis


Estimated Enrollment: 44
Study Start Date: October 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Microlipid and fish oil group
This group will be given early enteral lipid supplementation with Microlipid and fish oil.
Dietary Supplement: Microlipid and fish oil
Fish oil will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which both will be continued until reanastomosis.
Active Comparator: Microlipid group
This group will be given early enteral lipid supplementation only with Microlipid.
Dietary Supplement: Microlipid
A small amount (ml) of Microlipid to match the amount of fish oil in ML/FO group will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which will be continued until reanastomosis.

Detailed Description:

In comparison to EMLFO trial, the EMLFO-2 study will modify the eligibility criteria to only enroll the infants who have birthweight equal to or less than 1250 g with a jejunostomy or ileostomy as the result of surgical treatment for small intestine perforation or NEC in order to increase the homogeneity of patient population.

  Eligibility

Ages Eligible for Study:   up to 2 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. infants (age range: newborn to ≤ 2-month-old) whose birth weight are ≤ 1250g;
  2. who are admitted to BCH NICU for surgical intervention for NEC or small intestine perforation and then to have a jejunostomy or ileostomy;
  3. who are expected to need full or partial PN for at least 21days from the day of ostomy placement; and
  4. who have received enteral feedings ≤ 4 days since ostomy placement.

Exclusion Criteria:

  1. infant with birth weight > 1250g;
  2. infant with colostomy;
  3. infants with enterostomy but

    • unable to obtain written informed consent from parent;
    • presence of congenital liver, renal, or metabolic diseases or syndromes or perinatal asphyxia;
    • ostomy caused by surgical treatment for a condition other than NEC or small intestine perforation; and
    • unable to initiate enteral feeding for more than 28 days since 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: NCT01674478

Contacts
Contact: Qing Yang, MD, PhD 336-716-8687 qyang@wakehealth.edu

Locations
United States, North Carolina
Wake Forest University Health Science Recruiting
Winston Salem, North Carolina, United States, 27157
Contact: Qing Yang, MD, PhD    336-716-8687    qyang@wakehealth.edu   
Contact: Michael O'Shea, MD, MPH    336-716-4663    moshea@wakehealth.edu   
Principal Investigator: Qing Yang, MD, PhD         
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Qing Yang, MD, PhD WFUHS
  More Information

Publications:
Responsible Party: Qing Yang, Associate Professor of Pediatrics, Wake Forest University
ClinicalTrials.gov Identifier: NCT01674478     History of Changes
Other Study ID Numbers: WFIRB00021481
Study First Received: August 18, 2012
Last Updated: May 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
NEC, SBS, enterostomy, fish oil, Microlipid, Intralipid,
enteral fat

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

ClinicalTrials.gov processed this record on October 19, 2014