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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Biological: Umbilical Cord Blood Infusion
* Biological: Intravenous Infusion of Peripheral Blood or its Components


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Autologous cord blood transfusion<br>Treatment Group 1 Interventions: collected autologous whole cord blood at birth will be transfused for the preterm neonate | Biological: Umbilical Cord Blood Infusion<br>* 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.<br>* Other names: Whole Autologous Umbilical Cord Blood Infusion;|
| Sham Comparator: Standard treatment for neonatal anemia<br>Treatment Group 2 Interventions: transfusion of allogeneic whole peripheral blood or any of its components at a time of anemia of prematurity development | Biological: Intravenous Infusion of Peripheral Blood or its Components<br>* Regular treatment of neonatal anemia with peripheral blood or its components transfusion.<br>* Other names: Allogeneic peripheral blood or its components transfusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of autologous cord blood infusion in enrolled preterm neonates. | Confirm the safety of autologous cord blood infusion in preterm neonates by repeated follow-up over one year with clinical and laboratory evaluations. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of autologous cord blood infusion in enrolled preterm neonates. | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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, Vascular Diseases, Retinopathies, Neonates, Prevention,Treatment