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| ID | Type | Description | Link |
|---|---|---|---|
| CB-P#1 | Other Identifier | Department of General Pathology of PMU |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous cord blood transfusion | Active Comparator | Treatment Group 1 Interventions: collected autologous whole cord blood at birth will be transfused for the preterm neonate |
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| Standard treatment for neonatal anemia | Sham Comparator | Treatment Group 2 Interventions: transfusion of allogeneic whole peripheral blood or any of its components at a time of anemia of prematurity development |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical Cord Blood Infusion | Biological | Cord blood collection after delivery of the baby. Preservation of blood in blood bank. Transfusion of autologous cord blood within the first 5 postnatal days. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of autologous cord blood infusion in enrolled preterm neonates. | Confirm the safety of autologous cord blood infusion in preterm neonates by repeated follow-up over one year with clinical and laboratory evaluations. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of autologous cord blood infusion in enrolled preterm neonates. | Confirm the efficacy of autologous cord blood infusion in preterm neonates by repeated follow-up over one year with clinical and laboratory evaluations for neurodevelopmental and general health outcomes at 3, 6 and 12 months of age. Particularly, analysis of prematurity complications will be performed. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boguslaw Machalinski, MD, PhD, BSc | Department of General Pathology, Pomeranian Medical University in Szczecin, Poland | Study Chair |
| Jacek Rudnicki, MD, PhD, BSc | Department of Neonatology, Pomeranian Medical University in Szczecin, Poland | Study Director |
| Milosz Piotr Kawa, MD, PhD | Department of General Pathology, Pomeranian Medical University in Szczecin, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neonatology of Pomeranian Medical University in Szczecin, Poland | Szczecin | 70-111 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26643677 | Derived | Rudnicki J, Kawa MP, Kotowski M, Michalczyk B, Ustianowski P, Czajka R, Machalinski B. Clinical Evaluation of the Safety and Feasibility of Whole Autologous Cord Blood Transplant as a Source of Stem and Progenitor Cells for Extremely Premature Neonates: Preliminary Report. Exp Clin Transplant. 2015 Dec;13(6):563-72. |
| Label | URL |
|---|---|
| Website of the Pomeranian Medical University in Szczecin, Poland | View source |
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| Intravenous Infusion of Peripheral Blood or its Components | Biological | Regular treatment of neonatal anemia with peripheral blood or its components transfusion. |
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| ID | Term |
|---|---|
| D000751 | Anemia, Neonatal |
| D020300 | Intracranial Hemorrhages |
| D020345 | Enterocolitis, Necrotizing |
| D012127 | Respiratory Distress Syndrome, Newborn |
| D012178 | Retinopathy of Prematurity |
| D001997 | Bronchopulmonary Dysplasia |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D006402 | Hematologic Diseases |
| D008171 | Lung Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D006425 | Hemic and Lymphatic Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D009422 | Nervous System Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D012128 | Respiratory Distress Syndrome |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D005128 | Eye Diseases |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
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