Transfusions and Nitric Oxide Level in Preterm Infants

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.

Completed

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Key information

Conditions

Prematurity Anemia Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Intestinal Diseases Necrotizing Enterocolitis Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 365 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

SNOHgB Levels

Time frame: beginning and end of study

levels were never run by the laboratory

Secondary outcomes

Oxygen Saturation and Measures of Perfusion Pre and Post-transfusion.

Time frame: prior to, during, after transfusion

data not appropriately collected for the analysis due to machine malfunctions.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

Children's Miracle Network

Registry information

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Nov 7, 2008
Registry last updated: Sep 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed