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NCT01735578 · ClinicalTrials.gov registry record
Splanchnic Tissue Oxygenation During Enteral Feedings in Anemic Premature Infants at Risk for Necrotizing Enterocolitis
A clinical trial of Necrotizing Enterocolitis and Anemia of Prematurity, sponsored by University of Utah.
- Completed
- Registry status
- 52
- Enrollment target
- 1
- Study location
NCT01735578 is a study of Necrotizing Enterocolitis and Anemia of Prematurity that has completed, run by University of Utah. The registered enrollment target is 52 participants, below the 309-participant average among 14 other Necrotizing Enterocolitis trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01735578, a study of Necrotizing Enterocolitis and Anemia of Prematurity, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
Necrotizing enterocolitis (NEC) is the most common gastrointestinal emergency encountered in the newborn intensive care unit and represents a significant cause of morbidity and mortality in infants born prematurely. Among possible risk factors, a strong association between elective RBC transfusions in premature infants with anemia and the subsequent development of NEC has been consistently observed (6-11). However, a significant (and increasing) number of VLBW infants with anemia are managed with erythropoiesis stimulating agents (such as Epo) and iron and do not receive RBC transfusions during their hospital stay. The present study proposes to study this particular group of VLBW infants that remain with low (\<28 %) hematocrit while receiving full enteral feedings. The investigators hypothesize that significant anemia in VLBW infants will be associated with a baseline low cerebro-splanchnic oxygenation ratio (CSOR) (\<0.75) as measured by NIRS, and that nasogastric feedings (NGF) in those particular patients will lead to further decreased splanchnic oxygenation. The investigators further postulate that CSOR values will be significantly lower among VLBW that develop NEC as compared to infants that do not.
Conditions Studied
Study Locations (1)
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2012-10 |
| Est. Completion | 2015-04 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01735578
The ClinicalTrials.gov registry entry for NCT01735578 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 309-participant average among 14 other Necrotizing Enterocolitis trials with a reported enrollment target (83% lower). The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Necrotizing Enterocolitis appearing as the primary indexed condition, and to 0 interventions.
NCT01735578 reports 1 study location spanning 1 distinct geographic area - top geographies include Utah.
Frequently Asked Questions
What is clinical trial NCT01735578 about?
NCT01735578 is a clinical study titled "Splanchnic Tissue Oxygenation During Enteral Feedings in Anemic Premature Infants at Risk for Necrotizing Enterocolitis". Necrotizing enterocolitis (NEC) is the most common gastrointestinal emergency encountered in the newborn intensive care unit and represents a significant cause of morbidity and mortality in infants born prematurely. Among possible risk factors, a strong association between elective RBC transfusions ...
What is the current status of trial NCT01735578?
This trial is currently completed. The enrollment target is 52 participants. The study started on 2012-10. Estimated completion is 2015-04.
What conditions does trial NCT01735578 study?
This clinical trial studies the following conditions: Necrotizing Enterocolitis, Anemia of Prematurity.
Who is sponsoring clinical trial NCT01735578?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01735578 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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