Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Children's Miracle Network | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | < 28 weeks gestation, < 30 days of age, < 3 previous transfusions | ||
| 2 | < 28 weeks gestation, >=30 days of age, >= 3 previous transfusions |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| SNOHgB Levels | levels were never run by the laboratory | beginning and end of study |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Saturation and Measures of Perfusion Pre and Post-transfusion. | data not appropriately collected for the analysis due to machine malfunctions. | prior to, during, after transfusion |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Infants < 28 weeks gestation at birth undergoing a packed red blood cell transfusion
Not provided
| Name | Affiliation | Role |
|---|---|---|
| P Brian Smith, MD MHS | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | <30 Days | < 28 weeks gestation, < 30 days of age, < 3 previous transfusions |
| FG001 | >=30 | < 28 weeks gestation, >=30 days of age, >= 3 previous transfusions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | <30 Days | < 28 weeks gestation, < 30 days of age, < 3 previous transfusions |
| BG001 | >=30 | < 28 weeks gestation, >=30 days of age, >= 3 previous transfusions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Oxygen Saturation and Measures of Perfusion Pre and Post-transfusion. | data not appropriately collected for the analysis due to machine malfunctions. | Posted | prior to, during, after transfusion |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | <30 Days | < 28 weeks gestation, < 30 days of age, < 3 previous transfusions |
Not provided
Not provided
no AE observed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Smith | Duke University Medical Center | 9196688951 | brian.smith@duke.edu |
Not provided
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D000740 | Anemia |
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
blood specimens for measurement of SNO-Hb. Samples will be discarded after measurement.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
| Primary | SNOHgB Levels | levels were never run by the laboratory | Posted | beginning and end of study |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | >=30 | < 28 weeks gestation, >=30 days of age, >= 3 previous transfusions | 0 | 4 | 0 | 4 |
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |