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

Pomeranian Medical University Szczecin

Status and phase: Unknown; Phase 1

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

Treatments: Biological: Umbilical Cord Blood Infusion; Biological: Intravenous Infusion of Peripheral Blood or its Components

Study type: Interventional

Funder types: Other

Identifiers

NCT02050971

CB-P#1 (Other Identifier)

ZPO 01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: Under 30 days old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Autologous cord blood transfusion

Active Comparator group

Description:

Treatment Group 1 Interventions: collected autologous whole cord blood at birth will be transfused for the preterm neonate

Treatment:

Biological: Umbilical Cord Blood Infusion

Standard treatment for neonatal anemia

Sham Comparator group

Description:

Treatment Group 2 Interventions: transfusion of allogeneic whole peripheral blood or any of its components at a time of anemia of prematurity development

Treatment:

Biological: Intravenous Infusion of Peripheral Blood or its Components