Clinical trial NCT02050971: Autologous Cord Blood Infusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Anemia, Neonatal
Intracranial Hemorrhages
Necrotizing Enterocolitis
Respiratory Distress Syndrome, Newborn
Retinopathy of Prematurity
Bronchopulmonary Dysplasia
Keywords: 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
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 40
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Safety of autologous cord blood infusion in enrolled preterm neonates.
timeFrame: 1 year
Secondary outcomes:
measure: Efficacy of autologous cord blood infusion in enrolled preterm neonates.
timeFrame: 1 year
Other outcomes:
Locations:
city: Szczecin
country: Poland
facility: Department of Neonatology of Pomeranian Medical University in Szczecin, Poland
Study officials:
affiliation: Department of General Pathology, Pomeranian Medical University in Szczecin, Poland
name: Boguslaw Machalinski, MD, PhD, BSc
role: STUDY_CHAIR
affiliation: Department of Neonatology, Pomeranian Medical University in Szczecin, Poland
name: Jacek Rudnicki, MD, PhD, BSc
role: STUDY_DIRECTOR
affiliation: Department of General Pathology, Pomeranian Medical University in Szczecin, Poland
name: Milosz Piotr Kawa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rudnicki J, Kawa MP, Kotowski M, Michalczyk B, Ustianowski P, Czajka R, Machalinski B. Clinical Evaluation of the Safety and Feasibility of Whole Autologous Cord Blood Transplant as a Source of Stem and Progenitor Cells for Extremely Premature Neonates: Preliminary Report. Exp Clin Transplant. 2015 Dec;13(6):563-72.