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NCT01674478 · ClinicalTrials.gov registry record · Phase 2
Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies
A Phase 2 study, sponsored by Wake Forest University.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT01674478: Completed Phase 2 study, sponsored by Wake Forest University.
NCT01674478 is a Phase 2 study that has completed, run by Wake Forest University. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01674478, a Phase 2 study, has completed, sponsored by Wake Forest University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study 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 uncl
Primary Outcome
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
Interventions
- DIETARY_SUPPLEMENT Microlipid with fish oil
- DIETARY_SUPPLEMENT Microlipid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2012-10 |
| Est. Completion | 2015-03-17 |
| Phase | Phase 2 |
What the finished NCT01674478 record still lists
NCT01674478 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Microlipid with fish oil is the first listed.
NCT01674478 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01674478 about?
NCT01674478 is a clinical study titled "Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies". 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 m...
What is the current status of trial NCT01674478?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2012-10. Estimated completion is 2015-03-17.
What interventions are being tested in trial NCT01674478?
The interventions under investigation include: Microlipid with fish oil (DIETARY_SUPPLEMENT), Microlipid (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01674478?
This trial is sponsored by Wake Forest University, which has 100 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01674478's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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