Transfusions and Nitric Oxide Level in Preterm Infants

Completed

• Conditions: Anemia; Necrotizing Enterocolitis; Prematurity

• Registration Number: NCT00787124
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-11-06
• Study First Submitted QC: 2008-11-06
• Study First Posted: 2008-11-07
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2013-07-24
• Results First Submitted QC: 2013-12-13
• Results First Posted: 2014-01-15
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-31
• Last Update Posted: 2018-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SNOHgB Levels	beginning and end of study	levels were never run by the laboratory

Secondary Outcome Measures

Name	Time	Method
Oxygen Saturation and Measures of Perfusion Pre and Post-transfusion.	prior to, during, after transfusion	data not appropriately collected for the analysis due to machine malfunctions.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States