Transfusions and Nitric Oxide Level in Preterm Infants
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Transfusions and Nitric Oxide Level in Preterm Infants|
- SNOHgB Levels [ Time Frame: beginning and end of study ] [ Designated as safety issue: No ]levels were never run by the laboratory
- Oxygen Saturation and Measures of Perfusion Pre and Post-transfusion. [ Time Frame: prior to, during, after transfusion ] [ Designated as safety issue: No ]data not appropriately collected for the analysis due to machine malfunctions.
Biospecimen Retention: Samples Without DNA
blood specimens for measurement of SNO-Hb. Samples will be discarded after measurement.
|Study Start Date:||September 2008|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
Please refer to this study by its ClinicalTrials.gov identifier: NCT00787124
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||P Brian Smith, MD MHS||Duke University|