NCT00787124

Transfusions and Nitric Oxide Level in Preterm Infants

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 365 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Prematurity
• Anemia
• Necrotizing Enterocolitis

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2008-11-07
• Last updated: 2018-09-28
• Results posted: 2014-01-15

Locations

1 site across 1 country: United States