Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01674478
Recruitment Status : Completed
First Posted : August 28, 2012
Results First Posted : December 4, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Brief Summary:

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 or disease Intervention/treatment Phase
Prematurity Intestine Perforation Necrotizing Enterocolitis (NEC) Short Bowel Syndrome (SBS) Dietary Supplement: Microlipid with fish oil Dietary Supplement: Microlipid Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies
Actual Study Start Date : October 2012
Actual Primary Completion Date : March 17, 2015
Actual Study Completion Date : March 17, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ostomy
Drug Information available for: Fish oil

Arm Intervention/treatment
Experimental: Microlipid with fish oil group
This group will be given early enteral lipid supplementation with Microlipid and fish oil.
Dietary Supplement: Microlipid with 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.




Primary Outcome Measures :
  1. The Serum Biomarkers of Inflammatory Cytokines [ Time Frame: 2 years and 5 months ]
    Compare the serum biomarkers of 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

  2. The Serum Biomarkers of Oxidative Stress [ Time Frame: 2 years and 5 months ]
    Compare the serum biomarkers of oxidative stress 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 :
  1. The Average Enteral Calorie (Total Calorie) Intake Before Reanast [ Time Frame: 2 years and 5 months ]
    To compare the average enteral calorie (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

  2. The Average Weight Gain (g/Day) After Reanastomosis [ Time Frame: 2 years and 5 months ]
    To compare the the average weight gain (g/day) of infants receiving ML/FO to the infants only receiving ML after reanastomosis



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01674478


Locations
Layout table for location information
United States, North Carolina
Wake Forest University Health Science
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Investigators
Layout table for investigator information
Principal Investigator: Qing Yang, MD, PhD WFUHS

Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT01674478     History of Changes
Other Study ID Numbers: IRB00021481
First Posted: August 28, 2012    Key Record Dates
Results First Posted: December 4, 2018
Last Update Posted: December 4, 2018
Last Verified: November 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
NEC, SBS, enterostomy, fish oil, Microlipid, Intralipid,
enteral fat

Additional relevant MeSH terms:
Layout table for MeSH terms
Soybean oil, phospholipid emulsion
Enterocolitis
Enterocolitis, Necrotizing
Short Bowel Syndrome
Intestinal Perforation
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Malabsorption Syndromes
Postoperative Complications
Pathologic Processes
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions