N/A
N=8
Transfusions and Nitric Oxide Level in Preterm Infants
Prematurity · Anemia · Necrotizing Enterocolitis
Bottom Line
View on ClinicalTrials.gov: NCT00787124 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: SNOHgB Levels
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SNOHgB Levels |
— | — |
| SECONDARY Oxygen Saturation and Measures of Perfusion Pre and Post-transfusion. |
— | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00787124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.