CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 8 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT00787124
NCT00787124N/ACompleted

Transfusions and Nitric Oxide Level in Preterm Infants

Duke University·observational·Posted Nov 7, 2008·Updated Sep 28, 2018

In Brief

An observational study for Prematurity and 2 related conditions. Completed, enrolled 8 participants across 1 site.

Detailed Summary

The purpose of this study is to better understand S-nitrosohemeglobin (SNO-Hb) in transfused blood of extremely preterm infants. The long term goal of the project is to identify variation in the SNO-Hb between packed red blood cell units, and between and among individual preterm infants pre and post-transfusion. Duke investigators are developing methods to replenish SNO-Hb, which, if successful, would improve RBC deformation in addition to providing a vasodilatory stimulation to hypoxic tissue, and lead to a randomized clinical trial testing treated vs. untreated RBC transfusions in extremely premature infants. AIM 1. Measure the Total Hemoglobin (Hb)-bound nitric oxide (NO), Hb \[Fe\] NO, SNO-Hb (a calculated value = (total Hb-NO - Hb \[Fe\] NO) in blood to be transfused in extremely preterm babies, and in samples pre and post- transfusion from the babies. Hypothesis 1: Measures of NO and SNO-Hb will be low in blood used for transfusion in preterm infants and will be decreased in the post-transfusion samples from the infants compared with the pre-transfusion samples. AIM 2. Collect clinical data about study participants, including oxygen saturation and measures of perfusion pre and post-transfusion. Hypothesis 2: Measures of perfusion will be reduced by 20% post-transfusion in extremely preterm infants.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 7, 2008
Enrollment StartSep 1, 2008
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 17.7 years ago