Autologous Cord Blood Infusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates

NCT02050971 | Unknown Phase 1

• 2 other identifiers: ZPO 01CB-P#1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia, Neonatal; Intracranial Hemorrhages; Necrotizing Enterocolitis; Respiratory Distress Syndrome, Newborn; Retinopathy of Prematurity; Bronchopulmonary Dysplasia

Keywords

Umbilical Cord Blood; Autologous Umbilical Cord Blood Transfusion; Prematurity Complications; Infant, Premature, Diseases; Infant, Newborn, Diseases; Hematologic Diseases; Lung Diseases; Central Nervous System Diseases; Gastrointestinal Tract Diseases; Vascular Diseases; Retinopathies, Neonates; Prevention,Treatment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Efficacy of autologous cord blood infusion in enrolled preterm neonates.

  1 year

Study Arms (2)

Autologous cord blood transfusion

ACTIVE COMPARATOR

Treatment Group 1 Interventions: collected autologous whole cord blood at birth will be transfused for the preterm neonate

Biological: Umbilical Cord Blood Infusion

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

Biological: Intravenous Infusion of Peripheral Blood or its Components

Interventions

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.

Also known as: Whole Autologous Umbilical Cord Blood Infusion

Autologous cord blood transfusion

Intravenous Infusion of Peripheral Blood or its Components BIOLOGICAL

Regular treatment of neonatal anemia with peripheral blood or its components transfusion.

Also known as: Allogeneic peripheral blood or its components transfusion

Standard treatment for neonatal anemia

Eligibility Criteria

• Age: Up to 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• preterm neonates less than 34 weeks of gestation, who developed anemia of prematurity,
• available unit of autologous umbilical cord blood

You may not qualify if:

• major congenital or chromosomal abnormalities,
• intrauterine infection,
• cyanotic heart defect,
• chronic intrauterine hypoxia (defined as growth retardation or pathologies of placental perfusion),
• incompatibilities in main blood groups and Rh antygen,
• lack of parental consent for enrollment to the study,
• contraindications for cord blood collection (lack of consent, amniotic fluid leakage for longer than 6 hours or physical complications in the cord blood harvesting).

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

Study Sites (1)

Department of Neonatology of Pomeranian Medical University in Szczecin, Poland

Szczecin, 70-111, Poland

Location

Related Publications (1)

• 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.

  PMID: 26643677 DERIVED

Related Links

• Website of the Pomeranian Medical University in Szczecin, Poland

MeSH Terms

Conditions

Anemia, Neonatal; Intracranial Hemorrhages; Enterocolitis, Necrotizing; Respiratory Distress Syndrome, Newborn; Retinopathy of Prematurity; Bronchopulmonary Dysplasia; Infant, Premature, Diseases; Infant, Newborn, Diseases; Hematologic Diseases; Lung Diseases; Central Nervous System Diseases; Vascular Diseases; Retinal Diseases

Condition Hierarchy (Ancestors)

Anemia; Hemic and Lymphatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cerebrovascular Disorders; Brain Diseases; Nervous System Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Respiratory Distress Syndrome; Respiratory Tract Diseases; Respiration Disorders; Eye Diseases; Ventilator-Induced Lung Injury; Lung Injury

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Boguslaw Machalinski, Professor and Chief, Department of General Pathology, Pomeranian Medical University

Study Record Dates

• First Submitted: January 29, 2014
• First Posted: January 31, 2014
• Study Start: October 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: January 31, 2014

Record last verified: 2014-01

Locations

PL (1)