Anemia, Necrotizing Enterocolitis, Prematurity
Conditions
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.
Interventions
None listed
Sponsors
Children's Miracle Network
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 365 Days
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SNOHgB Levels | beginning and end of study | levels were never run by the laboratory |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Saturation and Measures of Perfusion Pre and Post-transfusion. | prior to, during, after transfusion | data not appropriately collected for the analysis due to machine malfunctions. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| <30 Days \< 28 weeks gestation, \< 30 days of age, \< 3 previous transfusions | 4 |
| >=30 \< 28 weeks gestation, \>=30 days of age, \>= 3 previous transfusions | 4 |
| Total | 8 |
Baseline characteristics
| Characteristic | >=30 | <30 Days | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 4 Participants | 4 Participants | 8 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 60 days STANDARD_DEVIATION 37 | 20 days STANDARD_DEVIATION 45 | 40 days STANDARD_DEVIATION 40 |
| Region of Enrollment United States | 4 participants | 4 participants | 8 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
Primary
SNOHgB Levels
levels were never run by the laboratory
Time frame: beginning and end of study
Secondary
Oxygen Saturation and Measures of Perfusion Pre and Post-transfusion.
data not appropriately collected for the analysis due to machine malfunctions.
Time frame: prior to, during, after transfusion