Transfusions and Nitric Oxide Level in Preterm Infants

This study has been completed.
Children's Miracle Network
Information provided by (Responsible Party):
Phillip Brian Smith, Duke University Identifier:
First received: November 6, 2008
Last updated: December 13, 2013
Last verified: December 2013

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.

Necrotizing Enterocolitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transfusions and Nitric Oxide Level in Preterm Infants

Resource links provided by NLM:

Further study details as provided by Duke University:

Primary Outcome Measures:
  • SNOHgB Levels [ Time Frame: beginning and end of study ] [ Designated as safety issue: No ]
    levels were never run by the laboratory

Secondary Outcome Measures:
  • Oxygen Saturation and Measures of Perfusion Pre and Post-transfusion. [ Time Frame: prior to, during, after transfusion ] [ Designated as safety issue: No ]
    data not appropriately collected for the analysis due to machine malfunctions.

Biospecimen Retention:   Samples Without DNA

blood specimens for measurement of SNO-Hb. Samples will be discarded after measurement.

Enrollment: 8
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions


Ages Eligible for Study:   up to 365 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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


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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00787124

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Children's Miracle Network
Principal Investigator: P Brian Smith, MD MHS Duke University
  More Information

No publications provided

Responsible Party: Phillip Brian Smith, Associate Professor, Duke University Identifier: NCT00787124     History of Changes
Other Study ID Numbers: Pro00007939
Study First Received: November 6, 2008
Results First Received: July 24, 2013
Last Updated: December 13, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Enterocolitis, Necrotizing
Hematologic Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents processed this record on April 17, 2014