Health TrialsbyHealthPanel

Personalizing Preterm Neonatal Transfusions With Fetal Hemoglobin-Enriched Cord Blood

ConditionsPrematurity ComplicationsAnemia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24-31
SponsorUniversity of Parma

About this trial

Long-term morbidities among very low birth weight infants remain a significant challenge. Oxidative stress is a key factor in the pathogenesis of 'free radical (FR) diseases of prematurity,' including retinopathy of prematurity, bronchopulmonary dysplasia, necrotizing enterocolitis, and intraventricular hemorrhage. Red blood cell (RBC) transfusions are recognized as a contributing factor to FR-related diseases. RBCs contain adult hemoglobin (HbA), which has a lower affinity for oxygen. This characteristic increases oxygen delivery and tissue uptake, leading to a potentially harmful state of hyperoxia and over-generation of FRs. The strategy employs a multidisciplinary approach to evaluate the impact of cord blood transfusions in anemic newborns. Results will be assessed in relation to short- and long-term neonatal outcomes to determine the effectiveness of this new preventive strategy. Improving the current data are critical for setting action priorities for and monitoring progress

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Preterm neonates born between 24+0 and 31+6 weeks of gestational age;

Requirement for at least one red blood cell transfusion during hospitalization, according to current Italian transfusion thresholds;

Written informed consent obtained from parents or legal guardians prior to any study procedure.

Disqualifiers

Gestational age > 32+0 weeks;

Pregnancy complicated by maternal-fetal alloimmunization (e.g., hemolytic disease of the newborn);

Pregnancy complicated by fetal hydrops;

Major congenital anomalies or genetic syndromes;

Trial design

Design model

Factorial

Treatments tested in this trial

  • Cord Blood Red Blood Cell Transfusion (CB-RBC)

    Combination product

    Transfusion of leukodepleted, gamma-irradiated cord blood-derived red blood cell concentrates (CB-RBC), prepared from donated public cord blood bank units, characterized by high fetal hemoglobin (HbF) content and administered according to standard neonatal transfusion thresholds

  • Adult Donor Red Blood Cell Transfusion (A-RBC)

    Other intervention

    Transfusion of leukodepleted, gamma-irradiated adult-donor derived red blood cell concentrates (A-RBC) administered according to standard neonatal transfusion thresholds.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Cord Blood Red Blood Cell Transfusion (CB-RBC)Experimental treatment 1 intervention
Group B: Adult Donor Red Blood Cell Transfusion (A-RBC)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of free radical-related morbidities in preterm neonates receiving CB-RBC transfusions

Composite incidence of: Retinopathy of prematurity (ROP) Bronchopulmonary dysplasia (BPD) Necrotizing enterocolitis (NEC) Intraventricular hemorrhage (IVH) diagnosed according to standard neonatal criteria. Metric / Unit Number (%) of infants with at least one morbidity

Time frame
From birth until hospital discharge or 36 weeks postmenstrual age

Secondary outcomes

1

Severity of retinopathy of prematurity

Severity of ROP classified according to the International Classification of Retinopathy of Prematurity. Metric / Unit ROP stage (Stage 0-5)

Time frame
Until hospital discharge or 44 weeks postmenstrual age
2

Severity of bronchopulmonary dysplasia

Severity of BPD classified according to Jensen criteria. Metric / Unit Mild / Moderate / Severe BPD

Time frame
At 36 weeks postmenstrual age
3

Bayley Scales of Infant Development score (Bayley-III)

Neurodevelopmental assessment performed using Bayley Scales of Infant and Toddler Development. Metric / Unit Composite cognitive, language, behavioral and motor scores Cognitive, language, and motor composite scores range from 40 to 160, with higher scores indicating better neurodevelopmental performance.

Time frame
At 12 months corrected age
4

Incidence of acute and delayed transfusion-related adverse events following CB-RBC transfusions

Assessment of adverse events associated with CB-RBC transfusions. Metric / Unit Number (percent) of participants with transfusion-related adverse events

Time frame
From the first CB-RBC transfusion to hospital discharge (up to 6 months)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Parma

Lead sponsor

Source ClinicalTrials.gov

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