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NCT01306838 · ClinicalTrials.gov registry record · Early Phase 1
Early Provision of Enteral Microlipid and Fish Oil to Infants With Enterostomy
A Early Phase 1 study of Short Bowel Syndrome and Necrotizing Enterocolitis, sponsored by Wake Forest University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT01306838: Completed Early Phase 1 study of Short Bowel Syndrome and Necrotizing Enterocolitis, sponsored by Wake Forest University.
NCT01306838 is a Early Phase 1 study of Short Bowel Syndrome and Necrotizing Enterocolitis that has completed, run by Wake Forest University. The registered enrollment target is 40 participants, below the 182-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01306838, a Early Phase 1 study of Short Bowel Syndrome and Necrotizing Enterocolitis, has completed, sponsored by Wake Forest University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Necrotizing enterocolitis (NEC) and intestinal perforation are common in premature infants. Often surgery is needed to remove the dead bowel and create an ostomy (a temporary intestinal opening on the infant's abdomen). Infants with ostomies cannot digest and absorb food well, and must receive nutrition through the blood stream, i.e. parental nutrition (PN). However, prolonged dependence on PN can severely damage the liver and gut. Therefore, giving nutrition through the gut, i.e. enteral nutrition, is the primary treatment for infants with ostomies. Enteral fats, especially polyunsaturated fatty acids (PUFA), are most beneficial in stimulating gut mucosal adaptation, which begins 24 to 48 hours following bowel resection. In addition, the premature intestine has a rapid growth rate. It is likely that the current clinical practice of giving a relatively low-fat diet to infants with ostomies may not meet their high metabolic needs. The investigators hypothesize that increasing dietary fat content by early supplementation with MicroLipid® (ML, n-6 PUFA) and fish oil (FO, n-3 PUFA) to preserve the proper balance of n-6 and n-3 PUFA, may (i) improve bowel adaptation and infant growth; (ii) reduce the use of PN; and (iii) prevent liver damage and/or cholestasis (jaundice) in infants with ostomies.
Primary Outcome
We hypothesize that the average duration of exposure to PN/IL of the infants receiving ML/FO will be less than that of infants receiving usual care. The ratio of enteral to parenteral nutrition in the infants receiving ML/FO will be greater than that of infants receiving usual care.
Conditions Studied
Interventions
- OTHER Routine care
- DIETARY_SUPPLEMENT MicroLipid and fish oil
Study Locations (1)
North Carolina
- WFUHS Brenner Children's Hospital NICU - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2009-10 |
| Est. Completion | 2014-10 |
| Phase | Early Phase 1 |
What the finished NCT01306838 record still lists
NCT01306838 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 182-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (78% lower).
The record links to 3 conditions, with Short Bowel Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Routine care is the first listed.
NCT01306838 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01306838 about?
NCT01306838 is a clinical study titled "Early Provision of Enteral Microlipid and Fish Oil to Infants With Enterostomy". Necrotizing enterocolitis (NEC) and intestinal perforation are common in premature infants. Often surgery is needed to remove the dead bowel and create an ostomy (a temporary intestinal opening on the infant's abdomen). Infants with ostomies cannot digest and absorb food well, and must receive nutri...
What is the current status of trial NCT01306838?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 40 participants. The study started on 2009-10. Estimated completion is 2014-10.
What conditions does trial NCT01306838 study?
This clinical trial studies the following conditions: Short Bowel Syndrome, Necrotizing Enterocolitis, Small Intestine Perforation.
What interventions are being tested in trial NCT01306838?
The interventions under investigation include: Routine care (OTHER), MicroLipid and fish oil (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01306838?
This trial is sponsored by Wake Forest University, which has 100 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01306838 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Short Bowel Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01306838's enrollment target sits among peer trials
40 12th of 17 higher than 5 of 17 other Short Bowel Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Short Bowel Syndrome 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.
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