| CTRI Number |
CTRI/2025/07/091783 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Umbilical cord blood transfusion as a replacement for adult blood transfusion in neonates] |
| Study Design |
Other |
|
Public Title of Study
|
Use of umbilical cord blood instead of adult blood for transfusion in newborn babies to check safety and effectiveness |
|
Scientific Title of Study
|
Umbilical cord blood transfusion as a replacement for adult blood transfusion in newborn |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivam Batham |
| Designation |
Resident Medical Officer |
| Affiliation |
Shyam Shah Medical College Rewa |
| Address |
Pediatrics Department Sanjay Gandhi Medical College and Hospital Rewa Madhya
Rewa
MADHYA PRADESH
486001
India |
| Phone |
7000809795 |
| Fax |
|
| Email |
bathamshivam0997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naresh Bajaj |
| Designation |
Professor and Head of Department |
| Affiliation |
Shyam Shah Medical College Rewa |
| Address |
Pediatrics Department Sanjay Gandhi Medical College and Hospital Rewa Madhya Pradesh
Rewa
MADHYA PRADESH
486001
India |
| Phone |
9399372171 |
| Fax |
|
| Email |
naresh30405@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Prakash Singh |
| Designation |
Assistant Professor |
| Affiliation |
Shyam Shah Medical College Rewa |
| Address |
Pediatrics Department Sanjay Gandhi Medical College and Hospital Rewa Madhya Pradesh
Rewa
MADHYA PRADESH
486001
India |
| Phone |
7415409136 |
| Fax |
|
| Email |
ravi.prakashsingh789@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pediatrics Department Shyam Shah Medical College Rewa Madhya Pradesh 486001 |
|
|
Primary Sponsor
|
| Name |
Shivam Batham |
| Address |
Department of pediatrics, SSMC REWA |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrNaresh Bajaj |
SNCU and NICU |
First floor, Department of Pediatrics
Rewa
MADHYA PRADESH |
9399372171
naresh30405@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SSMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P619||Perinatal hematological disorder,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adult human blood |
15 mL/kg of Adult human blood transfusion in neonates and pretransfusion and post transfusion parameters are assessed |
| Intervention |
Umbilical cord blood transfusion |
15 ml/kg of placental blood is transfused in neonates and Pretransfusiom and post transfusion parameters are assessed. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
New born patients requiring blood transfusion |
|
| ExclusionCriteria |
| Details |
Patients with major congenital malformation incompatible with life
Patients previously transfused with blood |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To establish the efficacy of umbilical cord blood as an alternative to adult human blood in newborns requiring transfusion |
6 month to 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To compare the rise in hemoglobin levels and red cell indices after transfusion with umbilical cord blood vs adult blood
2 To assess the quality index of stored umbilical cord blood compare to stored adult donor blood
3 To evaluate the impact of storage duration on the hematological indices of umbilical cord blood vs adult blood |
One year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
05/08/2025 |
| 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)
|
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
|
This study aims to evaluate the use of umbilical cord blood as a substitute for adult blood transfusion in newborns. Cord blood is collected from healthy deliveries, screened, and stored. A total of 100 neonates requiring transfusion will be included and randomly assigned to receive either cord blood or adult blood. The study compares efficacy by assessing hemoglobin rise, red cell indices, and storage quality of both blood types. It addresses the shortage of donor blood in neonatal care, especially in resource-limited settings. |