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NCT01937884 · ClinicalTrials.gov registry record · Phase 2
Supplemental Parenteral Nutrition in Pediatric Respiratory Failure
A Phase 2 study, sponsored by University of Arizona.
- Terminated
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT01937884 is a Phase 2 study that was terminated before completion, run by University of Arizona. The registered enrollment target is 18 participants.
The verdict
NCT01937884, a Phase 2 study, was terminated before completion, sponsored by University of Arizona.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
Optimal delivery of nutritional support during critical illness is central to appropriate intensive care unit management, and yet fundamental gaps in knowledge exist regarding timing, route, dose, and type of nutritional support for critically ill infants and children. Understanding how to optimize nutritional support during pediatric critical illness is important because even brief periods of malnutrition in infancy result in permanent negative effects on long-term neurocognitive development. Optimized nutrition support is a way to improve morbidity for survivors of pediatric critical illness. Parenteral nutrition (PN) supplementation could improve long-term neurocognitive outcome for pediatric critical illness by preventing acute malnutrition, but has unknown effects on intestinal barrier function; a proposed mechanism for late sepsis and infectious complications during critical illness. While randomized controlled trials (RCT) support early PN in premature infants and late PN in critically ill adults, the optimal time to begin PN is unknown for critically ill infants and children. Acute malnutrition may develop within 48 hours of admission in critically ill infants and children, and repleted energy stores are predictive of survival. And yet, due to concerns for PN-associated infectious morbidity, current PICU standard of care is to supplement with PN only in children who fail to enterally feed, as late as 7 days into their admission. Delays in nutrition may have long-term effects on cognitive outcome in older infants and children. In premature infants, PN begun within hours of birth results in improved 18-month neurocognitive outcome without an increase in infectious complications. An RCT is needed to determine if early PN in critically ill infants and children prevents acute malnutrition and improves short and long-term outcomes of PICU hospitalization. The central hypothesis of this proposal is that optimized early protein and calorie delivery will improve nu
Interventions
- DRUG Parenteral Nutrition
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2013-08 |
| Est. Completion | 2018-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01937884
The ClinicalTrials.gov registry entry for NCT01937884 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arizona, which has 349 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Parenteral Nutrition is the first listed.
NCT01937884 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01937884 about?
NCT01937884 is a clinical study titled "Supplemental Parenteral Nutrition in Pediatric Respiratory Failure". Optimal delivery of nutritional support during critical illness is central to appropriate intensive care unit management, and yet fundamental gaps in knowledge exist regarding timing, route, dose, and type of nutritional support for critically ill infants and children. Understanding how to optimize ...
What is the current status of trial NCT01937884?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2013-08. Estimated completion is 2018-08.
What interventions are being tested in trial NCT01937884?
The interventions under investigation include: Parenteral Nutrition (DRUG).
Who is sponsoring clinical trial NCT01937884?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
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