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CTRI Number  CTRI/2017/02/007924 [Registered on: 20/02/2017] Trial Registered Prospectively
Last Modified On: 19/09/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Blood product]  
Study Design  Single Arm Trial 
Public Title of Study   Babys own umbilical cord blood for transfusion in premature newborn babies 
Scientific Title of Study
Modification(s)  
Autologous umbilical cord blood for red cell concentrates (RCC) transfusion in preterm infants- An uncontrolled trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Thangaraj Abiramalatha 
Designation  Senior resident 
Affiliation  Department of Neonatology, Sri Ramachandra University, Porur, Chennai 
Address  F-1/3, DABC, Aishwaryam phase-2 Nolambur Chennai
Department of Neonatology, Sri Ramachandra University, Porur, Chennai-600116
Chennai
TAMIL NADU
600095
India 
Phone  9840857407  
Fax    
Email  abi_paeds@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Binu Ninan 
Designation  Professor and Head 
Affiliation  Department of Neonatology, Sri Ramachandra University, Porur, Chennai 
Address  No-31, Shanmugam flats, Pari Street, Mogappair East Chennai
Department of Neonatology, Sri Ramachandra University, Porur, Chennai-600116
Chennai
TAMIL NADU
600037
India 
Phone  9841283832  
Fax    
Email  drbinusss@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Thangaraj Abiramalatha 
Designation  Senior resident 
Affiliation  Department of Neonatology, Sri Ramachandra University, Porur, Chennai 
Address  F-1/3, DABC, Aishwaryam phase-2 Nolambur Chennai
Department of Neonatology, Sri Ramachandra University, Porur, Chennai-600116
Chennai
TAMIL NADU
600095
India 
Phone  9840857407  
Fax    
Email  abi_paeds@yahoo.com  
 
Source of Monetary or Material Support  
GATE fund Sri Ramachandra University, Porur, Chennai-600116 
 
Primary Sponsor  
Name  GATE fund Sri Ramachandra University 
Address  Sri Ramachandra University Porur, Chennai-600116 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Thangaraj Abiramalatha  Department of Neonatology, Sri Ramachandra University  Department of Neonatology, Sri Ramachandra University Porur, Chennai-600116
Chennai
TAMIL NADU 
9840857407

abi_paeds@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Ramachandra Medical College and Research Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  D759||Disease of blood and blood-formingorgans, unspecified,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Autologous umbilical cord blood  Autologous umbilical cord blood for red cell concentrates transfusion in preterm infants 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria
Modification(s)  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  Premature infants <30 weeks gestational age and/or <1200g estimated fetal weight, who are delivered by vaginal delivery or caesarean section 
 
ExclusionCriteria 
Details  Lack of consent
Mothers positive for HIV, HBsAg, HCV or VDRL
Clinical or proven chorioamnionitis
Mother who opt for cord blood banking
Major congenital anomalies or genetic syndromes
Maternal-fetal iso-immunization
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Number of Red cell concentrates transfusions from Umbilical cord blood  Till 3 weeks of life 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
• Number of UCB units of adequate quantity (15ml/kg) and quality that could be collected
• Number of units of adequate quality (biochemical and hematological)
o On day 7
o On day 14
o On day 21
• Incidence of transfusion reactions
 
First 3 weeks of life 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)
Modification(s)  
01/05/2018 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   The trial will be published in an indexed, peer-reviewed journal 
Brief Summary
Modification(s)  

Umbilical cord blood will be collected under strict aseptic precautions in both vaginal delivery and caesarean section. The collection bag will be transported to the blood bank immediately or stored at 2-6oC. In the blood bank, RCC will be separated from the UCB by refrigerated centrifugation at 1800 revolutions per minute (rpm) for 10 minutes. RCC will be stored at 2-6oC. 

Quality Indicators

Blood culture (from the separated RCC) 

Further at one-week interval

·      pH and lactate in blood gas analyzer

·      Biochemical - Potassium, glucose 

·      Hematological

o   Complete blood count (CBC) - Hematocrit, mean corpuscular volume (MCV), platelet count, leucocyte count 

o   Free plasma hemoglobin


Clinical use

UCB will be used only after confirming that the initial culture is sterile.  
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