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

NCT02050971 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-01-31

No results posted yet for this study

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.

Conditions

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

Interventions

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.

BIOLOGICAL

Intravenous Infusion of Peripheral Blood or its Components

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

Sponsors & Collaborators

  • Pomeranian Medical University Szczecin

    lead OTHER

Principal Investigators

  • Boguslaw Machalinski, MD, PhD, BSc · Department of General Pathology, Pomeranian Medical University in Szczecin, Poland

  • Jacek Rudnicki, MD, PhD, BSc · Department of Neonatology, Pomeranian Medical University in Szczecin, Poland

  • Milosz Piotr Kawa, MD, PhD · Department of General Pathology, Pomeranian Medical University in Szczecin, Poland

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2014-12-31
Completion
2015-12-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02050971 on ClinicalTrials.gov