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.

Study Overview

• Status: Completed
• Conditions: Anemia; Necrotizing Enterocolitis; Prematurity

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Infants < 28 weeks gestation at birth undergoing a packed red blood cell transfusion

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1; < 28 weeks gestation, < 30 days of age, < 3 previous transfusions
2; < 28 weeks gestation, >=30 days of age, >= 3 previous transfusions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SNOHgB Levels	levels were never run by the laboratory	beginning and end of study

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Children's Miracle Network
• Investigators: Principal Investigator: P Brian Smith, MD MHS, Duke University

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: November 6, 2008
• First Submitted That Met QC Criteria: November 6, 2008
• First Posted (Estimate): November 7, 2008

Study Record Updates

• Last Update Posted (Actual): September 28, 2018
• Last Update Submitted That Met QC Criteria: August 31, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Enterocolitis; Enterocolitis, Necrotizing
• Other Study ID Numbers: Pro00007939