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

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Pomeranian Medical University Szczecin

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Pomeranian Medical University Szczecin

Dates:
Date Received: January 29, 2014
Date Started: October 2010
Date Completion: December 2015
Last Updated: January 30, 2014
Last Verified: January 2014