Transfusions and Nitric Oxide Level in Preterm Infants

Anemia Clinical Trial

Official title:

Transfusions and Nitric Oxide Level in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00787124
• Other study ID #: Pro00007939
• Status: Completed
• Start date: September 2008
• Est. completion date: September 2009

Study information

• Verified date: August 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 365 Days

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis
• Prematurity

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Children's Miracle Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SNOHgB Levels	levels were never run by the laboratory	beginning and end of study
Secondary	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