Transfusions and Nitric Oxide Level in Preterm Infants

Completed

Conditions studied: Prematurity, Anemia, Necrotizing Enterocolitis

In brief

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.

Key facts

Study ID

NCT00787124

Run by

Duke University

People needed

8

Starts

2008-09-01

Expected to finish

2009-09-01

Last updated by the study team

2018-09-28

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Any concomitant condition, which in the opinion of the investigator would preclude a patient's participation in the study
• Previous participation in the study.

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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