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NCT01062815 · ClinicalTrials.gov registry record · NA
Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants
A NA study, sponsored by University of Miami.
- Terminated
- Registry status
- NA
- Development phase
- 48
- Enrollment target
NCT01062815: Clinical Trial NA study, sponsored by University of Miami.
NCT01062815 is a NA study that was terminated before completion, run by University of Miami. The registered enrollment target is 48 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01062815, a NA study, was terminated before completion, sponsored by University of Miami.
- TERMINATED
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
Study Summary
Hypothesis to be Tested: Since the first description of intravenous alimentation over half a century ago, parenteral nutrition (PN) has become a common nutritional intervention for conditions characterized by inability to tolerate enteral feeds such as Short Bowel Syndrome, Chronic Intestinal Pseudoobstruction, Microvillus Inclusion Disease, Crohn's disease, multi-organ failure and prematurity. Parenteral Nutrition-Associated Liver Disease (PNALD) encompasses a spectrum of disease including cholestasis, hepatitis, steatosis and gallbladder sludge/stones which may progress to liver cirrhosis and even failure. There is a direct correlation between duration of parenteral nutrition and development of cholestasis in infants. There is evidence in animals and humans that cycling of parental nutrition, defined as infusing nutrients over a time period shorter than 24 hours, reduces cholestasis. There is also data that premature infants with gestational age (GA) \< 32 weeks and birth weight \<1500g, as well as infants with congenital anomalies of the gastrointestinal tract, are among those at highest risk of developing Parenteral Nutrition-Associated Cholestasis (PNAC). We therefore hypothesize that infants with gestational age (GA) \<32 weeks and birth weight (BW) between \<1500g, or with congenital anomaly of the gastrointestinal tract regardless of GA or BW, receiving PN over a period of 20 hours will have a decrease severity of PNAC, demonstrated by a lower peak direct bilirubin, compared to a similar control population receiving standard 24 hour infusion.
Interventions
- DIETARY_SUPPLEMENT Parenteral Nutrition
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2009-02 |
| Est. Completion | 2010-06 |
| Phase | NA |
Why NCT01062815 stopped before completion
NCT01062815 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Parenteral Nutrition is the first listed.
NCT01062815 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01062815 about?
NCT01062815 is a clinical study titled "Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants". Hypothesis to be Tested: Since the first description of intravenous alimentation over half a century ago, parenteral nutrition (PN) has become a common nutritional intervention for conditions characterized by inability to tolerate enteral feeds such as Short Bowel Syndrome, Chronic Intestinal Pseud...
What is the current status of trial NCT01062815?
This trial is currently terminated. It is a NA study. The enrollment target is 48 participants. The study started on 2009-02. Estimated completion is 2010-06.
What interventions are being tested in trial NCT01062815?
The interventions under investigation include: Parenteral Nutrition (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01062815?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01062815's enrollment target sits among peer trials
48 1381st of 2000 higher than 601 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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