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 Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02050971
• Other study ID #: ZPO 01
• Secondary ID: CB-P#1
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: January 29, 2014
• Last updated: January 30, 2014
• Start date: October 2010
• Est. completion date: December 2015

Study information

• Verified date: January 2014
• Source: Pomeranian Medical University Szczecin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Days

Eligibility

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

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

Related Conditions & MeSH terms

• Anemia, Neonatal
• Bronchopulmonary Dysplasia
• Enterocolitis
• Enterocolitis, Necrotizing
• Intracranial Hemorrhages
• Necrotizing Enterocolitis
• Premature Birth
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Biological:
• Umbilical Cord Blood Infusion
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.
• Intravenous Infusion of Peripheral Blood or its Components
Regular treatment of neonatal anemia with peripheral blood or its components transfusion.

Locations

Country	Name	City	State
Poland	Department of Neonatology of Pomeranian Medical University in Szczecin, Poland	Szczecin

Sponsors (1)

Lead Sponsor	Collaborator
Pomeranian Medical University Szczecin

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No

External Links

•   Website of the Pomeranian Medical University in Szczecin, Poland