Transfusions and Nitric Oxide Level in Preterm Infants
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Duke University
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- SNOHgB Levels
Study Overview
Brief 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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 365 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Infant < 28 weeks gestation at birth
- •Undergoing PRBC transfusion with a volume ≥ 10 cc/kg
- •Availability and willingness of the parent/legally authorized representative to provide written informed consent.
Exclusion Criteria
- •Any concomitant condition, which in the opinion of the investigator would preclude a patient's participation in the study
- •Previous participation in the study.
Outcomes
Primary Outcomes
SNOHgB Levels
Time Frame: beginning and end of study
levels were never run by the laboratory
Secondary Outcomes
- Oxygen Saturation and Measures of Perfusion Pre and Post-transfusion.(prior to, during, after transfusion)
Investigators
Phillip Brian Smith
Associate Professor
Duke University