Transfusions and Nitric Oxide Level in Preterm Infants

NCT00787124 | Completed Results

• 1 other identifier: Pro00007939
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Prematurity; Anemia; Necrotizing Enterocolitis

Outcome Measures

Primary Outcomes (1)

• SNOHgB Levels

  levels were never run by the laboratory

  beginning and end of study

Secondary Outcomes (1)

• Oxygen Saturation and Measures of Perfusion Pre and Post-transfusion.

  prior to, during, after transfusion

Study Arms (2)

1

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

2

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

Eligibility Criteria

• Age: Up to 365 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Any concomitant condition, which in the opinion of the investigator would preclude a patient's participation in the study
• Previous participation in the study.

Sponsors & Collaborators

• Duke University: lead
• Children's Miracle Network: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Premature Birth; Anemia; Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Limitations and Caveats

no AE observed

Results Point of Contact

• Title: Brian Smith
• Organization: Duke University Medical Center

brian.smith@duke.edu

9196688951

Study Officials

• P Brian Smith, MD MHS

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 6, 2008
• First Posted: November 7, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 28, 2018
• Results First Posted: January 15, 2014

Record last verified: 2018-08

Locations

US (1)