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| Sponsors and Collaborators: |
Duke University Children's Miracle Network |
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| Information provided by: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00787124 |
Purpose
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 |
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Prematurity Anemia Necrotizing Enterocolitis |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Transfusions and Nitric Oxide Level in Preterm Infants |
blood specimens for measurement of SNO-Hb. Samples will be discarded after measurement.
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2008 |
| Groups/Cohorts |
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1
< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
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2
< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
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Eligibility| Ages Eligible for Study: | up to 365 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Infants < 28 weeks gestation at birth undergoing a packed red blood cell transfusion
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: | P Brian Smith, MD MHS | Duke University |
More Information
| Responsible Party: | Duke University Medical Center ( P. Brian Smith, Assistant Professor ) |
| Study ID Numbers: | Pro00007939 |
| Study First Received: | November 6, 2008 |
| Last Updated: | May 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00787124 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Vasodilator Agents Neurotransmitter Agents Antioxidants Gastrointestinal Diseases Anemia Necrotizing Enterocolitis Anti-Asthmatic Agents Cardiovascular Agents |
Intestinal Diseases Enterocolitis Nitric Oxide Digestive System Diseases Peripheral Nervous System Agents Enterocolitis, Necrotizing Gastroenteritis Bronchodilator Agents |
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Respiratory System Agents Vasodilator Agents Neurotransmitter Agents Antioxidants Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Physiological Effects of Drugs Anti-Asthmatic Agents Cardiovascular Agents Intestinal Diseases Protective Agents Enterocolitis |
Pharmacologic Actions Nitric Oxide Digestive System Diseases Autonomic Agents Therapeutic Uses Free Radical Scavengers Endothelium-Dependent Relaxing Factors Peripheral Nervous System Agents Enterocolitis, Necrotizing Gastroenteritis Bronchodilator Agents |
