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Safety and Effectiveness Phase 1 Study of Autologous Umbilical Cord Blood Transfusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates
The purpose of this study is to test the safety and effectiveness of a whole own (autologous) umbilical cord blood transfusion in the first 5 days after birth if the baby is born premature \<34 weeks and developed anemia of prematurity.
The purpose of this pilot study is to conduct the investigation of the safety and efficacy of autologous cord blood infusion in premature neonates who demonstrate anemia due to prematurity (most common prematurity complication). However, premature infants reveal a high risk of other acute complications, including brain injury (e.g., intraventricular hemorrhage; IVH), necrotizing enterocolitis (NEC), and neonatal respiratory distress syndrome (RDS), as well as retinopathy of prematurity (ROP) and bronchopulmonary dysplasia (BPD). Therefore, prematurity is considered one of the main causes of neonatal deaths. The preterm neonates need transfusion of allogenic whole peripheral blood or any of its components at a time of anemia of prematurity development. In contrast, other prematurity complications do not have effective treatment nor preventive strategies. We will enroll premature neonates born premature (\<34 weeks of gestation) who developed anemia of prematurity and had their own autologous cord blood collected for subsequent transfusion. Next, we will test tolerability, safety and efficacy of autogenic whole cord blood infusion and evaluate the frequency of premature complications in neonates after transfusion. Besides, this pilot study will test feasibility of technical collection, preparation and infusion of a neonate's own umbilical cord blood within the first 5 days after birth.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
No
Department of Neonatology of Pomeranian Medical University in Szczecin, Poland
Szczecin, Poland
Start Date
October 1, 2010
Primary Completion Date
December 1, 2014
Completion Date
December 1, 2015
Last Updated
January 31, 2014
40
ESTIMATED participants
Umbilical Cord Blood Infusion
BIOLOGICAL
Intravenous Infusion of Peripheral Blood or its Components
BIOLOGICAL
Lead Sponsor
Pomeranian Medical University Szczecin
NCT00747851
NCT03210831
NCT06727877
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