Transfusions and Nitric Oxide Level in Preterm Infants

Duke University

Status: Completed

Conditions: Anemia; Prematurity; Necrotizing Enterocolitis

Study type: Observational

Funder types: Other

Identifiers

NCT00787124

Pro00007939

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: Under 365 days old

Volunteers: No Healthy Volunteers

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.

Trial design

8 participants in 2 patient groups

1

Description:

\< 28 weeks gestation, \< 30 days of age, \< 3 previous transfusions

2

Description:

\< 28 weeks gestation, \>=30 days of age, \>= 3 previous transfusions