Clinical Trials Logo
  1. Home
  2. Retinopathy of Prematurity
  3. NCT02050971

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

Bronchopulmonary Dysplasia Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02050971
Study type Interventional
Source Pomeranian Medical University Szczecin
Contact
Status Enrolling by invitation
Phase Phase 1
Start date October 2010
Completion date December 2015
View Details
See also
  Status Clinical Trial Phase
Terminated NCT04506619 - Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
Completed NCT04936477 - Ventilation-perfusion (V/Q) Ratio and Alveolar Surface Area in Preterm Infants N/A
Recruiting NCT05285345 - Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease
Completed NCT03649932 - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing Phase 1
Terminated NCT02524249 - Early Versus Late Caffeine for ELBW Newborns N/A
Completed NCT02249143 - Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants N/A
Active, not recruiting NCT01632475 - Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
Completed NCT01460576 - Improving Prematurity-Related Respiratory Outcomes at Vanderbilt N/A
Completed NCT00419588 - Growth of Airways and Lung Tissues in Premature and Healthy Infants
Unknown status NCT00254176 - Cysteine Supplementation in Critically Ill Neonates Phase 2/Phase 3
Completed NCT00208039 - Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates N/A
Completed NCT00319956 - Trial II of Lung Protection With Azithromycin in the Preterm Infant Phase 2
Completed NCT00006401 - Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants Phase 3
Terminated NCT05030012 - Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants N/A
Completed NCT00006058 - Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns N/A
Completed NCT00005376 - Premature Birth and Its Sequelae in Women N/A
Completed NCT00011362 - Dexamethasone Therapy in VLBW Infants at Risk of CLD Phase 3
Completed NCT00004805 - Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death N/A
Completed NCT05152316 - The Baby Lung Study
Recruiting NCT04821453 - NAVA vs. CMV Crossover in Severe BPD N/A