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

January 30, 2014 updated by: Milosz Kawa, Pomeranian Medical University Szczecin

Safety and Effectiveness Phase 1 Study of Autologous Umbilical Cord Blood Transfusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Szczecin, Poland, 70-111
        • Department of Neonatology of Pomeranian Medical University in Szczecin, Poland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Allogeneic peripheral blood or its components transfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

January 29, 2014

First Submitted That Met QC Criteria

January 30, 2014

First Posted (Estimate)

January 31, 2014

Study Record Updates

Last Update Posted (Estimate)

January 31, 2014

Last Update Submitted That Met QC Criteria

January 30, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZPO 01
  • CB-P#1 (Other Identifier: Department of General Pathology of PMU)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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