Autologous Cord Blood Infusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates
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|ClinicalTrials.gov Identifier: NCT02050971|
Recruitment Status : Unknown
Verified January 2014 by Milosz Kawa, Pomeranian Medical University Szczecin.
Recruitment status was: Enrolling by invitation
First Posted : January 31, 2014
Last Update Posted : January 31, 2014
|Condition or disease||Intervention/treatment||Phase|
|Anemia, Neonatal Intracranial Hemorrhages Necrotizing Enterocolitis Respiratory Distress Syndrome, Newborn Retinopathy of Prematurity Bronchopulmonary Dysplasia||Biological: Umbilical Cord Blood Infusion Biological: Intravenous Infusion of Peripheral Blood or its Components||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Effectiveness Phase 1 Study of Autologous Umbilical Cord Blood Transfusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2015|
Active Comparator: Autologous cord blood transfusion
Treatment Group 1 Interventions: collected autologous whole cord blood at birth will be transfused for the preterm neonate
Biological: Umbilical Cord Blood Infusion
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.
Other Name: Whole Autologous Umbilical Cord Blood Infusion
Sham Comparator: Standard treatment for neonatal anemia
Treatment Group 2 Interventions: transfusion of allogeneic whole peripheral blood or any of its components at a time of anemia of prematurity development
Biological: Intravenous Infusion of Peripheral Blood or its Components
Regular treatment of neonatal anemia with peripheral blood or its components transfusion.
Other Name: Allogeneic peripheral blood or its components transfusion
- Safety of autologous cord blood infusion in enrolled preterm neonates. [ Time Frame: 1 year ]Confirm the safety of autologous cord blood infusion in preterm neonates by repeated follow-up over one year with clinical and laboratory evaluations.
- Efficacy of autologous cord blood infusion in enrolled preterm neonates. [ Time Frame: 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02050971
|Department of Neonatology of Pomeranian Medical University in Szczecin, Poland|
|Szczecin, Poland, 70-111|
|Study Chair:||Boguslaw Machalinski, MD, PhD, BSc||Department of General Pathology, Pomeranian Medical University in Szczecin, Poland|
|Study Director:||Jacek Rudnicki, MD, PhD, BSc||Department of Neonatology, Pomeranian Medical University in Szczecin, Poland|
|Principal Investigator:||Milosz Piotr Kawa, MD, PhD||Department of General Pathology, Pomeranian Medical University in Szczecin, Poland|