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

Primary Purpose

Anemia, Neonatal, Intracranial Hemorrhages, Necrotizing Enterocolitis

Status
Unknown status
Phase
Phase 1
Locations
Poland
Study Type
Interventional
Intervention
Umbilical Cord Blood Infusion
Intravenous Infusion of Peripheral Blood or its Components
Sponsored by
Pomeranian Medical University Szczecin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anemia, Neonatal focused on measuring 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

Eligibility Criteria

undefined - 30 Days (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Department of Neonatology of Pomeranian Medical University in Szczecin, Poland

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Autologous cord blood transfusion

Standard treatment for neonatal anemia

Arm Description

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

Treatment Group 2 Interventions: transfusion of allogeneic whole peripheral blood or any of its components at a time of anemia of prematurity development

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 29, 2014
Last Updated
January 30, 2014
Sponsor
Pomeranian Medical University Szczecin
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1. Study Identification

Unique Protocol Identification Number
NCT02050971
Brief Title
Autologous Cord Blood Infusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates
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 Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pomeranian Medical University Szczecin

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autologous cord blood transfusion
Arm Type
Active Comparator
Arm Description
Treatment Group 1 Interventions: collected autologous whole cord blood at birth will be transfused for the preterm neonate
Arm Title
Standard treatment for neonatal anemia
Arm Type
Sham Comparator
Arm Description
Treatment Group 2 Interventions: transfusion of allogeneic whole peripheral blood or any of its components at a time of anemia of prematurity development
Intervention Type
Biological
Intervention Name(s)
Umbilical Cord Blood Infusion
Other Intervention Name(s)
Whole Autologous Umbilical Cord Blood Infusion
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Intravenous Infusion of Peripheral Blood or its Components
Other Intervention Name(s)
Allogeneic peripheral blood or its components transfusion
Intervention Description
Regular treatment of neonatal anemia with peripheral blood or its components transfusion.
Primary Outcome Measure Information:
Title
Safety of autologous cord blood infusion in enrolled preterm neonates.
Description
Confirm the safety of autologous cord blood infusion in preterm neonates by repeated follow-up over one year with clinical and laboratory evaluations.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Efficacy of autologous cord blood infusion in enrolled preterm neonates.
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boguslaw Machalinski, MD, PhD, BSc
Organizational Affiliation
Department of General Pathology, Pomeranian Medical University in Szczecin, Poland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jacek Rudnicki, MD, PhD, BSc
Organizational Affiliation
Department of Neonatology, Pomeranian Medical University in Szczecin, Poland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Milosz Piotr Kawa, MD, PhD
Organizational Affiliation
Department of General Pathology, Pomeranian Medical University in Szczecin, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neonatology of Pomeranian Medical University in Szczecin, Poland
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
26643677
Citation
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.
Results Reference
derived
Links:
URL
http://www.pum.edu.pl
Description
Website of the Pomeranian Medical University in Szczecin, Poland

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

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