NCT02050971

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Pomeranian Medical University Szczecin · Academic / Other
• Sex: All
• Age: 30 Days
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-12-01
• Completion: 2015-12-01
• First posted: 2014-01-31
• Last updated: 2014-01-31

Locations

1 site across 1 country: Poland