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CTRI Number  CTRI/2026/02/103939 [Registered on: 16/02/2026] Trial Registered Prospectively
Last Modified On: 14/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Transfusing blood concentrates derived from umbilical cord (of genetically different donors) versus adult-donors for anemia in preterm neonates 
Scientific Title of Study   Allogenic Umbilical Cord versus Adult RBC Concentrates Transfusion for Anemia in Preterm Neonates: a Randomized Controlled Trial 
Trial Acronym  AUmCARA_Neo 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SUMAN CHAURASIA 
Designation  Associate professor 
Affiliation  AIIMS, Rishikesh 
Address  Room 016117, Department of Neonatology

Dehradun
UTTARANCHAL
249203
India 
Phone  9971197833  
Fax    
Email  sumanyss@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SUMAN CHAURASIA 
Designation  Associate professor 
Affiliation  AIIMS, Rishikesh 
Address  Room 016117, Department of Neonatology

Dehradun
UTTARANCHAL
249203
India 
Phone  9971197833  
Fax    
Email  sumanyss@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SUMAN CHAURASIA 
Designation  Associate professor 
Affiliation  AIIMS, Rishikesh 
Address  Room 016117, Department of Neonatology

Dehradun
UTTARANCHAL
249203
India 
Phone  9971197833  
Fax    
Email  sumanyss@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research (ICMR) (under Small grants investigator initiated trial) 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Rishikesh 
Address  Vir Bhadra Road, Rishikesh, Dehradun Pin 249203 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Suman Chaurasia  Assoc Prof, Dept of Neonatology, Vir Bhadra Road, Rishikesh, Dehradun Pin 249203 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SUMAN CHAURASIA  AIIMS, Rishikesh  Ward 3048, Neonatal Intensive Care Unit, Level 3, B Block, Hospital Building, Department of Neonatology,All India Institute of Medical Sciences, Rishikesh Dehradun UTTARANCHAL
Dehradun
UTTARANCHAL 		 09971197833

sumanyss@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D648||Other specified anemias,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Adult-donor PRBC concentrates (standard practice)  Comparison group will receive adult-donor PRBC concentrates as per standard practice. 
Intervention  Allogenic umbilical cord PRBC concentrates  Umbilical cord blood harvested from placenta (after delayed cord clamping or appropriate cord management plan) of eligible consenting full term LSCS mothers under aseptic precautions, appropriate processing and storage will be done following standard guidelines in the blood bank. Intervention arm neonates will receive the Umblilical PRBC after standard cross matching and testing (subject to availability).  
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  30.00 Day(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  maternal-fetal isoimmunization including hydrops fetalis, major congenital malformations, previously transfused, critically sick neonate
requiring immediate transfusion 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of composite outcome of mortality and Retinopathy of Prematurity (ROP)
requiring treatment 		 at discharge or 40w PMA, whichever earlier 
 
Secondary Outcome  
Outcome  TimePoints 
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) 		 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) 		 at discharge or 40w PMA, whichever earlier (except specified) 
Neonates: Pre- and post-transfusion biochemical parameters pH,
potassium, lactate 		 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 rate  		 At the time of collection except when specified 
incidence of total adverse events during transfusions
and those that could be attributed to previous transfusions  		 at discharge or 40w PMA, whichever earlier 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   26/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Rationale:  Anemia requiring red blood cell (RBC) transfusion- a common problem in NICU- is primarily treated by repeated transfusion of adult-donor RBC (aPRBC). Its grave association with retinopathy of prematurity (ROP) in neonates- possibly due to early non-physiological replacement of HemoglobinF (HbF) with HbA, can be treated by replenishing HbF. Novelty Promising interim results of an Italian multi-site RCT (umBilical blOod to tRansfuse preterm Neonates - BORN trial) demonstrated feasibility and safety of allogenic umbilical cord red blood concentrates (uPRBC) transfusion in neonates. The novel use of cord blood, rendering waste to biologicals may be worthwhile for resource constrained settings, yet challenges of unchartered territory are expected. 
Aim:  To demonstrate Umbilical Packed Red Blood Cells harvest is feasible and transfusion safe, and evaluate if its transfusion in early life can prevent mortality and severe ROP in very preterm neonates.






Hypothesis and research question: uPRBC transfusion compared to aPRBC in preterm neonates requiring transfusion therapy for anemia reduces the composite outcome of mortality and ROP requiring treatment significantly. In neonates born before 30w GA requiring transfusion for anemia (diagnosed by 32w PMA) (P), can umbilical cord (I) versus adult (C) donor derived RBC concentrates can significantly reduce the composite outcome of ROP requiring treatment* and mortality (O), at 40 weeks PMA or discharge, whichever is earlier (T)? (*Type I ROP (Type I ROP: Zone1 any stage with plus, zone1 stage3 with no plus, and zone2 stage2 or 3 with plus) and aggressive ROP)
Objectives:  
Primary
To evaluate reduction in combined outcome of mortality and ROP requiring treatment among preterm neonates (<30w gestational age) being transfused uPRBC versus aPRBC for anemia.
Secondary
(i) To assess the incidence of severe (stage >3) ROP, bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC), hemodynamically significant PDA (hs PDA), intraventricular hemorrhage (IVH), sepsis (ii)To assess transfusion needs/efficacy and relevant biochemical parameters Hb/hematocrit change, transfusion frequency, interval between consecutive transfusions, median HbF level day 14 and 28 of transfusion 
(iii) To determine the incidence of total adverse events during transfusions and those that could be attributed to previous transfusions; proportion of protocol deviations
Methods:  Along with ethical approvals, SOPs/checklists for rigorously standardizing processes will be undertaken. uPRBC processed from cord blood harvested from consenting pregnant females undergoing LSCS at term, will be stored appropriately by our blood-centre research team. Neonates (<30w GA having anemia <32w PMA) will be randomized to receive uPRBC (arm A) or aPRBC (arm B) dispensed in identical-looking bags. Transfusions will be closely monitored for adverse events (if any) and reported to DSMB. The subjects will be screened for ROP until discharge or 40w PMA. An intention-to-treat analysis will be done. 
Expected: outcome Demonstrating harvest is feasible and transfusion safe, uPRBC transfusion in early life maybe recommended for preventing mortality and severe ROP in very preterm neonates. 
 
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