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CTRI Number  CTRI/2016/12/007536 [Registered on: 06/12/2016] Trial Registered Prospectively
Last Modified On: 12/06/2017
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Feasibility and safety of Umbilical cord blood as a potential source for blood transfusion in neonates. 
Scientific Title of Study   Feasibility and safety of Umbilical cord blood as a potential source for blood transfusion in neonates - Prospective cohort study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrMoluganM 
Designation  DM post graduate 
Affiliation  Madras Medical college 
Address  Department of Neonatology, Institute of Child health and Hospital for Children, Egmore, Chennai - 600008
Room No-6,old boys Hostel.Egmore children hospital.egmore.chennai-600008
Chennai
TAMIL NADU
600008
India 
Phone  09600058821  
Fax    
Email  drmolugan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrMangala BharathiS 
Designation  Associate Professor of Neonatology 
Affiliation  Madras Medical college 
Address  Department of Neonatology, Institute of Child Health and Hospital for Children, Egmore

Chennai
TAMIL NADU
600008
India 
Phone  09840786836  
Fax    
Email  drmangalabharathi@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrMangala BharathiS 
Designation  Associate Professor of Neonatology 
Affiliation  Madras Medical college 
Address  Department of Neonatology, Institute of Child Health and Hospital for Children, Egmore

Chennai
TAMIL NADU
600008
India 
Phone  09840786836  
Fax    
Email  drmangalabharathi@gmail.com  
 
Source of Monetary or Material Support  
Institute of Child Health and hospital for ChildrenDepartment of Neonatology 
 
Primary Sponsor  
Name  Institute of Child Health and hospital for ChildrenDepartment of Neonatology 
Address  Department of Neonatology, Institute of Child Health and Hospital for Children, Egmore, Chennai 600008 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrMoluganM  Institute of Child health and Hospital for children, Inborn unit, egmore   Department of Neonatology, Institute of Child Health and Hospital for Children, Egmore-, Chennai-600008
Chennai
TAMIL NADU 		 09600058821

drmolugan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee ,. Madras Medical College. Reg No. - ECR/270/Inst /TN/2013. Dated 06 - 09 -2016. Study No. - 04092016   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  umbilical cord blood collection and storage,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  umbilical cord blood collection and storage.  Following delivery of baby and delayed cord clamping (1-3 minutes), Umbilical cord blood collected from umbilical vein via gravity into a collection bag containing citrate anticoagulant and stored. The changes in parameters of stored blood are assessed at different intervals following blood collection - pH, Potassium, and Haematocrit at 0,7,14,21 and 30 days; Free Haemoglobin at 0, 14, 28 days; cord blood cultured at 0,14 days . The yield of RBCs estimated after centrifugation of stored blood at 2250 rpm for 12 min at 22 degree Celsius. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  1.00 Day(s)
Gender  Both 
Details  Mothers who consent for collection and storage of their Umbilical cord blood at the time of delivery 
 
ExclusionCriteria 
Details  1. Mothers diagnosed with HIV/HBV/HCV/Malaria/Syphilis infection
2. Mothers who opt for stem cell storage from Umbilical cord blood.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Quantity of umbilical cord blood (ml) that can be collected per neonate across different gestational age, birth weight, mode of delivery and collection method 2. Change in Parameters of collected and stored
umbilical cord blood
• pH (0, 7, 14, 21, 30 days)
• Potassium (0, 7,14,21,30 days)
• Haematocrit (0, 7,14,21,30 days)
• Free Haemoglobin (0, 14, 28days)
• Cord blood culture (0,14 days)

 		 0, 7, 14, 21, 30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Quantity of packed RBC(ml) that can be
separated from the umbilical cord blood after
collection. 		 day 1 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/12/2016 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Hypothesis of this study-It is feasible to separate and store packed red blood cell from umbilical cord blood and use it as a source for neonatal blood transfusion when required.primary purpose of this study to estimate the amount of umbilical cord blood that can be collected per neonate following delayed cord clamping across  different gestational ages,birth weight,mode of delivery and methods of collection.safety of the umbilical cord blood in terms of hematological,microbiological and biochemical quality on storage. 
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