Transfusing blood concentrates derived from umbilical cord (of genetically different donors) versus adult-donors for anemia in preterm neonates

Allogenic Umbilical Cord versus Adult RBC Concentrates Transfusion for Anemia in Preterm Neonates: a Randomized Controlled Trial - AUmCARA_Neo

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/103939

Enrollment

Registered

2026-02-16

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D648- Other specified anemias

Interventions

Intervention1: Allogenic umbilical cord PRBC concentrates: Umbilical cord blood harvested from placenta (after delayed cord clamping or appropriate cord management plan) of eligible consenting full te

Eligibility

Inclusion criteria

Inclusion criteria: all neonates born less than 30 w gestation in the index hospital who require transfusion therapy for anemia -according to unit protocol, before 32w PMA

Exclusion criteria

Exclusion criteria: maternal-fetal isoimmunization including hydrops fetalis, major congenital malformations, previously transfused, critically sick neonate requiring immediate transfusion

Design outcomes

Primary

Measure	Time frame
Incidence of composite outcome of mortality and Retinopathy of Prematurity (ROP) requiring treatmentTimepoint: at discharge or 40w PMA, whichever earlier	—

Secondary

Measure	Time frame
Incidence of other co-morbidities: severe ROP (stage 3 or above), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC), hemodynamically significant PDA (hs PDA), intraventricular hemorrhage (IVH), sepsis (clinical and culture-positive)Timepoint: at discharge or 40w PMA, whichever earlier;Change in Hb/hematocrit after transfusion, number of transfusions required, interval between consecutive transfusions, HbF level (at transfusion day 14 and 28)Timepoint: at discharge or 40w PMA, whichever earlier (except specified);Neonates: Pre- and post-transfusion biochemical parameters pH, potassium, lactateTimepoint: Whenever transfused;Pre-transfusion bag data: cord blood volume, RBC recovery volume, residual leukocyte count, Hb/haematocrit, pH, potassium, lactate, interval since collection: (Mean (SD) or Median (IQR)); proportion of culture positives and utilization rate at end of study (consumed/total harvested), end of-storage hemolysis rateTimepoint: At the time of collection except when specified;incidence of total adverse events during transfusions and those that could be attributed to previous transfusionsTimepoint: at discharge or 40w PMA, whichever earlier	—

Measure

Time frame

Incidence of other co-morbidities: severe ROP (stage 3 or above), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC), hemodynamically significant PDA (hs PDA), intraventricular hemorrhage (IVH), sepsis (clinical and culture-positive)Timepoint: at discharge or 40w PMA, whichever earlier;Change in Hb/hematocrit after transfusion, number of transfusions required, interval between consecutive transfusions, HbF level (at transfusion day 14 and 28)Timepoint: at discharge or 40w PMA, whichever earlier (except specified);Neonates: Pre- and post-transfusion biochemical parameters pH, potassium, lactateTimepoint: Whenever transfused;Pre-transfusion bag data: cord blood volume, RBC recovery volume, residual leukocyte count, Hb/haematocrit, pH, potassium, lactate, interval since collection: (Mean (SD) or Median (IQR)); proportion of culture positives and utilization rate at end of study (consumed/total harvested), end of-storage hemolysis rateTimepoint: At the time of collection except when specified;incidence of total adverse events during transfusions and those that could be attributed to previous transfusionsTimepoint: at discharge or 40w PMA, whichever earlier

—

Countries

India

Contacts

Public ContactDR SUMAN CHAURASIA

AIIMS, Rishikesh

sumanyss@gmail.com9971197833

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026