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Transfusions and Nitric Oxide Level in Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00787124
Recruitment Status : Completed
First Posted : November 7, 2008
Results First Posted : January 15, 2014
Last Update Posted : September 28, 2018
Children's Miracle Network
Information provided by (Responsible Party):
Phillip Brian Smith, Duke University

Brief 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.

Condition or disease
Prematurity Anemia Necrotizing Enterocolitis

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Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transfusions and Nitric Oxide Level in Preterm Infants
Study Start Date : September 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. SNOHgB Levels [ Time Frame: beginning and end of study ]
    levels were never run by the laboratory

Secondary Outcome Measures :
  1. 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.

Biospecimen Retention:   Samples Without DNA
blood specimens for measurement of SNO-Hb. Samples will be discarded after measurement.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 365 Days   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00787124

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Children's Miracle Network
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Principal Investigator: P Brian Smith, MD MHS Duke University
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Responsible Party: Phillip Brian Smith, Associate Professor, Duke University Identifier: NCT00787124    
Other Study ID Numbers: Pro00007939
First Posted: November 7, 2008    Key Record Dates
Results First Posted: January 15, 2014
Last Update Posted: September 28, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Enterocolitis, Necrotizing
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases