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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Milosz Kawa, Pomeranian Medical University Szczecin
ClinicalTrials.gov Identifier:
NCT02050971
First received: January 29, 2014
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention 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
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Pomeranian Medical University Szczecin:

Primary Outcome Measures:
  • Safety of autologous cord blood infusion in enrolled preterm neonates. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Confirm the safety of autologous cord blood infusion in preterm neonates by repeated follow-up over one year with clinical and laboratory evaluations.


Secondary Outcome Measures:
  • Efficacy of autologous cord blood infusion in enrolled preterm neonates. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: October 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02050971

Locations
Poland
Department of Neonatology of Pomeranian Medical University in Szczecin, Poland
Szczecin, Poland, 70-111
Sponsors and Collaborators
Pomeranian Medical University Szczecin
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Milosz Kawa, Boguslaw Machalinski, Professor and Chief, Department of General Pathology, Pomeranian Medical University, Pomeranian Medical University Szczecin
ClinicalTrials.gov Identifier: NCT02050971     History of Changes
Other Study ID Numbers: ZPO 01, CB-P#1
Study First Received: January 29, 2014
Last Updated: January 30, 2014
Health Authority: Poland: Institutional Review Board

Keywords provided by Pomeranian Medical University Szczecin:
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

Additional relevant MeSH terms:
Hemorrhage
Respiratory Distress Syndrome, Newborn
Retinal Diseases
Enterocolitis, Necrotizing
Retinopathy of Prematurity
Bronchopulmonary Dysplasia
Enterocolitis
Intracranial Hemorrhages
Anemia, Neonatal
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Eye Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ventilator-Induced Lung Injury
Lung Injury
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014