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

NCT ID: NCT02050971

Last Updated: 2014-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Keywords

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Autologous cord blood transfusion

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

Group Type ACTIVE_COMPARATOR

Umbilical Cord Blood Infusion

Intervention Type 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.

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

Group Type SHAM_COMPARATOR

Intravenous Infusion of Peripheral Blood or its Components

Intervention Type BIOLOGICAL

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

Interventions

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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.

Intervention Type BIOLOGICAL

Intravenous Infusion of Peripheral Blood or its Components

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Whole Autologous Umbilical Cord Blood Infusion Allogeneic peripheral blood or its components transfusion

Eligibility Criteria

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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).
Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pomeranian Medical University Szczecin

OTHER

Sponsor Role lead

Responsible Party

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Milosz Kawa

Boguslaw Machalinski, Professor and Chief, Department of General Pathology, Pomeranian Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Boguslaw Machalinski, MD, PhD, BSc

Role: STUDY_CHAIR

Department of General Pathology, Pomeranian Medical University in Szczecin, Poland

Jacek Rudnicki, MD, PhD, BSc

Role: STUDY_DIRECTOR

Department of Neonatology, Pomeranian Medical University in Szczecin, Poland

Milosz Piotr Kawa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of General Pathology, Pomeranian Medical University in Szczecin, Poland

Locations

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Department of Neonatology of Pomeranian Medical University in Szczecin, Poland

Szczecin, , Poland

Site Status

Countries

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Poland

References

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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.

Reference Type DERIVED
PMID: 26643677 (View on PubMed)

Related Links

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http://www.pum.edu.pl

Website of the Pomeranian Medical University in Szczecin, Poland

Other Identifiers

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CB-P#1

Identifier Type: OTHER

Identifier Source: secondary_id

ZPO 01

Identifier Type: -

Identifier Source: org_study_id