Ignite Creation Date:
2024-05-06 @ 12:51 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01674478
Status:
COMPLETED
Last Update Posted:
2018-12-04
First Post:
2012-08-18
Brief Title:
Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies
Sponsor:
Wake Forest University
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMLFO-2
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 MLFO we were able to decrease the use of IL b premature infants in the treatment group who received MLFO achieved higher enteral calorie of total calorie intake before reanastomosis and better weight gain gday 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 ie FO it is unclear whether improved outcomes in the MLFO group are attributable to FOs 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
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 MLFO we were able to decrease the use of IL b premature infants in the treatment group who received MLFO achieved higher enteral calorie of total calorie intake before reanastomosis and better weight gain gday 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 ie FO it is unclear whether improved outcomes in the MLFO group are attributable to FOs 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None