Transfusions and Nitric Oxide Level in Preterm Infants
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|ClinicalTrials.gov Identifier: NCT00787124|
Recruitment Status : Completed
First Posted : November 7, 2008
Results First Posted : January 15, 2014
Last Update Posted : September 28, 2018
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.
|Condition or disease|
|Prematurity Anemia Necrotizing Enterocolitis|
|Study Type :||Observational|
|Actual Enrollment :||8 participants|
|Official Title:||Transfusions and Nitric Oxide Level in Preterm Infants|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
- SNOHgB Levels [ Time Frame: beginning and end of study ]levels were never run by the laboratory
- Oxygen Saturation and Measures of Perfusion Pre and Post-transfusion. [ Time Frame: prior to, during, after transfusion ]data not appropriately collected for the analysis due to machine malfunctions.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00787124
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||P Brian Smith, MD MHS||Duke University|