Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
8 participants
OBSERVATIONAL
2008-09-30
2009-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Normal Hemostasis Values in Premature Infants
NCT07349251
Combining Restrictive Guidelines and a NIRS SCORE to Decrease RBC Transfusions
NCT02535208
Time Outside Target Oxygen Saturation Range in Preterm Infants and Long Term Outcomes and Preterm Infants
NCT00845624
Placental Transfusion in Term Infants: A Pilot Study
NCT01924572
N-Terminal Pro-B-Type Natriuretic Peptide and Troponin Levels as Markers of Hemodynamic Stability in Very Low Birth Weight Infants During the First Days of Life
NCT00425581
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
\< 28 weeks gestation, \< 30 days of age, \< 3 previous transfusions
No interventions assigned to this group
2
\< 28 weeks gestation, \>=30 days of age, \>= 3 previous transfusions
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Previous participation in the study.
365 Days
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Children's Miracle Network
OTHER
Duke University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Phillip Brian Smith
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
P Brian Smith, MD MHS
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Duke University Medical Center
Durham, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00007939
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.