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Transfusions and Nitric Oxide Level in Preterm Infants

This study has been completed.
Sponsor:
Collaborator:
Children's Miracle Network
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00787124
First received: November 6, 2008
Last updated: May 4, 2009
Last verified: May 2009
History of Changes
  Purpose

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
Prematurity
Anemia
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:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • The primary objective is to measure the Total Hb-bound 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. [ Time Frame: beginning and end of transfusion ] [ Designated as safety issue: No ]

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 ]

Biospecimen Retention:   Samples Without DNA

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


Estimated Enrollment: 10
Study Start Date: September 2008
Groups/Cohorts
1
< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
2
< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT00787124

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

No publications provided

Responsible Party: P. Brian Smith, Assistant Professor, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00787124     History of Changes
Other Study ID Numbers: Pro00007939
Study First Received: November 6, 2008
Last Updated: May 4, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anemia
Enterocolitis
Enterocolitis, Necrotizing
Hematologic Diseases
Gastroenteritis
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
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on May 22, 2013