- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02050971
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
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
-
-
-
Szczecin, Poland, 70-111
- Department of Neonatology of Pomeranian Medical University in Szczecin, Poland
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-
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
|
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:
|
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
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Regular treatment of neonatal anemia with peripheral blood or its components transfusion.
Other Names:
|
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.
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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
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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.
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1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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.
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
- Vascular Diseases
- 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
- Retinopathies, Neonates
- Prevention,Treatment
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Eye Diseases
- Hematologic Diseases
- Gastrointestinal Diseases
- Infant, Newborn, Diseases
- Gastroenteritis
- Intestinal Diseases
- Anemia
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Lung Injury
- Infant, Premature, Diseases
- Ventilator-Induced Lung Injury
- Retinal Diseases
- Hemorrhage
- Premature Birth
- Enterocolitis
- Enterocolitis, Necrotizing
- Intracranial Hemorrhages
- Retinopathy of Prematurity
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Bronchopulmonary Dysplasia
- Anemia, Neonatal
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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