Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies (EMLFO-2)
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|ClinicalTrials.gov Identifier: NCT01674478|
Recruitment Status : Completed
First Posted : August 28, 2012
Results First Posted : December 4, 2018
Last Update Posted : December 4, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- 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
- 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
- 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
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
|United States, North Carolina|
|Wake Forest University Health Science|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Qing Yang, MD, PhD||WFUHS|