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NCT01735552 · ClinicalTrials.gov registry record
Transfusion-related Inflammatory Cytokine and Neutrophil Extracellular Trap Quantification in Neonates
A clinical trial, sponsored by University of Utah.
- Terminated
- Registry status
- 12
- Enrollment target
NCT01735552 is a clinical trial that was terminated before completion, run by University of Utah. The registered enrollment target is 12 participants.
The verdict
NCT01735552 was terminated before completion, sponsored by University of Utah.
- TERMINATED
- Registry status
- 12 participants
- Enrollment target
Study Summary
Despite many advances in neonatal care, necrotizing enterocolitis (NEC) remains a leading cause of morbidity and mortality among premature infants. NEC is the most common life-threatening gastrointestinal emergency encountered in the neonatal intensive care unit, affecting between 3.8% and 13% of very low birthweight (VLBW) infants (1-3). More recently interest has intensified regarding the possible association between "elective" red blood cell (RBC) transfusions in premature infants and the subsequent development of NEC (4-9). On a physiological basis, a few explanations for transfusion-associated NEC have been proposed: 1) the physiological impact of anemia that can initiate a cascade of events leading to ischemic-hypoxemic mucosal gut injury predisposing to NEC \[10\]; and 2) increased splanchnic blood flow following RBC transfusion leading to reperfusion injury of gut mucosa. Aim 1. This study will quantify inflammatory cytokine profiles in anemic infants cared for in the NICU prior to and after transfusion with packed red blood cells (PRBC), as dictated by current clinical guidelines for treatment of anemia, and prospectively assess for clinical signs and symptoms of NEC following each transfusion event. Aim 2. Polymorphonuclear leukocytes (PMNs) isolated from the pre- and post-transfusion blood samples will be assessed in vitro for neutrophil extracellular traps (NET) formation. Aim 3. A) To determine whether significant anemia preceding a RBC transfusion is associated with impaired intestinal oxygenation, and whether a RBC transfusion temporarily increases splanchnic oxygenation. We postulate that the CSOR will be low (\<0.75) at baseline measurement in infants with hemodynamically significant anemia, and that RBC transfusion will temporarily increase intestinal perfusion in that particular group of babies. B) To determine whether alterations in mesenteric regional oxygenation saturation(rSO2) can predict the development of NEC in VLBW infants. We hypothe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2012-06 |
| Est. Completion | 2015-04 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01735552
The ClinicalTrials.gov registry entry for NCT01735552 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01735552 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01735552 about?
NCT01735552 is a clinical study titled "Transfusion-related Inflammatory Cytokine and Neutrophil Extracellular Trap Quantification in Neonates". Despite many advances in neonatal care, necrotizing enterocolitis (NEC) remains a leading cause of morbidity and mortality among premature infants. NEC is the most common life-threatening gastrointestinal emergency encountered in the neonatal intensive care unit, affecting between 3.8% and 13% of ve...
What is the current status of trial NCT01735552?
This trial is currently terminated. The enrollment target is 12 participants. The study started on 2012-06. Estimated completion is 2015-04.
Who is sponsoring clinical trial NCT01735552?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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