Red Blood Cell (RBC) Survival Following Transfusion in Infants
Neonatal Anemia
About this trial
This is an interventional basic science trial for Neonatal Anemia
Eligibility Criteria
Adult Study:
Inclusion Criteria:
- Males or post-menopausal females
- 18-65 years of age.
- Weight >110 lbs.
- Healthy- the subject feels well and can perform normal activities.
Hemoglobin at or above 12.5 g/dL or hematocrit at or above 38%.
- Note: Members of the research team that are not supervised or under the employee of the PI may participate in the study.
Exclusion Criteria:
- Presence of chronic illness unless the subject is being treated and the condition is under control.
- Consumption of biotin supplements or raw eggs.
- Premenopausal women.
- Blood donation in the previous 8 weeks (single donation) or 16 weeks (double red cell donation).
- Blood loss in the previous 8 weeks due to epistaxis, gastrointestinal blood loss, trauma, significant diagnostic phlebotomy loss (i.e., > 30 mL total), or other significant bleeding
Treatment with antibiotics within the last 7 days. Antibiotics for prevention of an infection or treatment of acne are not exclusion criteria.
- Note: If study subjects experience any of these conditions associated with blood loss or donate any blood products, they will not be included in the primary analysis but will be replaced.
Infant Study:
MOTHERS FOR PLACENTAL BLOOD COLLECTION AND MOTHERS OF INFANT STUDY SUBJECTS
Inclusion Criteria:
- >/= 24 weeks gestation
- mothers who deliver through the birth canal or by c-section can be included in the study.
Exclusion Criteria:
- Pregnant with fetus with major congenital anomaly.
- Clinically suspected or documented maternal chorioamnionitis (This only applies to infant study subjects receiving autologous RBCs from the placenta).
- Viral or bacterial infection (e.g. HIV, Hepatitis B, Hepatitis C, Primary Herpes, Tuberculosis) based on clinically available prenatal or postnatal test results in the mother's medical record. (This only applies to infant study subjects receiving autologous RBCs from the placenta.)
- minor mothers (<18 years old) are excluded from the study.
INFANT STUDY SUBJECTS
Inclusion Criteria:
Newborns >/=24 weeks gestation who are patients in the Neonatal Intensive Care Unit (NICU) at UIHC that:
1) Are being treated with the expectation of survival.
Exclusion Criteria:
- Difference of more than 5% in the percentage of HbF cells (measured by flow cytometry in the Widness lab) between blood harvested from the placenta and that from discarded neonatal blood in the first day of life and before the first neonatal blood transfusion. This is done to exclude the rare possibility of transfusing newborns with blood that is contaminated with a significant proportion of their mother's blood if a maternal-to-placenta bleed occurs after umbilical cord clamping is done. (This only applies to infant study subjects receiving autologous RBCs from the placenta.)
- Need of emergent blood transfusion as determined by the subject's medical care team.
- Hematological diseases (except for anemia associated with phlebotomy loss and prematurity)
- Alloimmune hemolytic anemia, diffuse intravascular coagulation, and thrombosis.
- Major congenital anomaly.
- Sepsis with positive blood or spinal fluid culture.
- Receiving treatment with erythropoietin (r-HuEPO) or cardiorespiratory bypass support (ECMO).
- Overt clinical bleeding.
Sites / Locations
- University of Iowa Hospitals and Clinics
- University of Iowa
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
PPG1A - Adults
PPG1B - Infants
Phase I completed: Healthy male and post-menopausal female volunteers between the ages of 18 and 65. Volunteers must not have donated blood in the previous 8 weeks.
Phase II in progress: Newborns >= 24 weeks gestation who are patients in the Neonatal Intensive Care Unit at the University of Iowa Hospitals and Clinics that are being treated with the expectation of survival.