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

Phase 1

• Conditions: Anemia, Neonatal; Intracranial Hemorrhages; Necrotizing Enterocolitis; Retinopathy of Prematurity; Bronchopulmonary Dysplasia; Respiratory Distress Syndrome, Newborn
• Interventions: Biological: Umbilical Cord Blood Infusion; Biological: Intravenous Infusion of Peripheral Blood or its Components

• Registration Number: NCT02050971
• Lead Sponsor: Pomeranian Medical University Szczecin

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 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 Timeline

• Study Start: 2010-10
• Status Verified: 2014-01
• Study First Submitted: 2014-01-29
• Study First Submitted QC: 2014-01-30
• Last Update Submitted: 2014-01-30
• Study First Posted: 2014-01-31
• Last Update Posted: 2014-01-31
• Primary Completion: 2014-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous cord blood transfusion	Umbilical Cord Blood Infusion	Treatment Group 1 Interventions: collected autologous whole cord blood at birth will be transfused for the preterm neonate
Standard treatment for neonatal anemia	Intravenous Infusion of Peripheral Blood or its Components	Treatment Group 2 Interventions: transfusion of allogeneic whole peripheral blood or any of its components at a time of anemia of prematurity development

Primary Outcome Measures

Name	Time	Method
Safety of autologous cord blood infusion in enrolled preterm neonates.	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.

Secondary Outcome Measures

Name	Time	Method
Efficacy of autologous cord blood infusion in enrolled preterm neonates.	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.

Trial Locations

Locations (1)

Department of Neonatology of Pomeranian Medical University in Szczecin, Poland; 🇵🇱 Szczecin, Poland