A Phase 2 interventional study of Microlipid with fish oil and Microlipid in Prematurity, Intestine Perforation and Necrotizing Enterocolitis (NEC), sponsored by Wake Forest University. Completed at 1 site in United States. Open to participants aged 1 Day to 2 Months. Per ClinicalTrials.gov, last updated 2018-12-04.
Sponsored by Wake Forest University · Phase 2, Interventional, and Prevention
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.
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.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 18 is below the median of 84 across 1,666 interventional studies indexed under Premature Birth.
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Exclusion Criteria:
infants with enterostomy but
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group will be given early enteral lipid supplementation with Microlipid and fish oil.
Dietary Supplement: Microlipid with fish oil
This group will be given early enteral lipid supplementation only with Microlipid.
Dietary Supplement: Microlipid
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.
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
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
Time frame: 2 years and 5 months
The Serum Biomarkers of Oxidative Stress
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
Time frame: 2 years and 5 months
The Average Enteral Calorie (Total Calorie) Intake Before Reanast
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
Time frame: 2 years and 5 months
The Average Weight Gain (g/Day) After Reanastomosis
To compare the the average weight gain (g/day) of infants receiving ML/FO to the infants only receiving ML after reanastomosis
Time frame: 2 years and 5 months
| Milestone | Microlipid and Fish Oil Group | Microlipid Group |
|---|---|---|
| Started | 9 | 9 |
| Completed | 9 | 9 |
| Not completed | 0 | 0 |
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
No measurements were reported for this outcome.
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
| kcal/kg/day | Microlipid and Fish Oil Group | Microlipid Group |
|---|---|---|
| The Average Enteral Calorie (Total Calorie) Intake Before Reanast | 52.1 ± 23.6 | 56.7 ± 15.6 |
To compare the the average weight gain (g/day) of infants receiving ML/FO to the infants only receiving ML after reanastomosis
| g/d | Microlipid and Fish Oil Group | Microlipid Group |
|---|---|---|
| The Average Weight Gain (g/Day) After Reanastomosis | 26.6 ± 8.5 | 20.9 ± 12.2 |
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
No measurements were reported for this outcome.
Collected over 2 years and 5 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Microlipid and Fish Oil Group | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Microlipid Group | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Continuous(weeks) | Microlipid and Fish Oil Group | Microlipid Group | Total |
|---|---|---|---|
| Mean | 26.3 ± 2.0 | 25.9 ± 2.0 | 26.1 ± 2.0 |
| Sex: Female, Male(Participants) | Microlipid and Fish Oil Group | Microlipid Group | Total |
|---|---|---|---|
| Female | 4 | 3 | 7 |
| Male | 5 | 6 | 11 |
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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