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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01306838
The ClinicalTrials.gov registry entry for NCT01306838 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 182-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (78% lower). The listed sponsor is Wake Forest University, which has 100 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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