| CTRI Number |
CTRI/2025/04/085194 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
20/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Umbilical cord blood transfusion] |
| Study Design |
Other |
|
Public Title of Study
|
Umbilical cord blood transfusion for preterm infants |
|
Scientific Title of Study
|
Umbilical cord blood as a source of blood transfusion in preterm infants |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Borkar Shankar Dattatray |
| Designation |
PG resident |
| Affiliation |
Shyam Shah Medical College |
| Address |
Dept of Pediatrics,Shyam Shah Medical College,Rewa
Rewa
MADHYA PRADESH
486001
India |
| Phone |
9545789413 |
| Fax |
|
| Email |
borkarshankar7781@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naresh Bajaj |
| Designation |
Professor |
| Affiliation |
Shyam Shah Medical College |
| Address |
Dept of Pediatrics,Shyam Shah Medical College,Rewa
Rewa
MADHYA PRADESH
486001
India |
| Phone |
9399372171 |
| Fax |
|
| Email |
naresh30405@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naresh Bajaj |
| Designation |
Professor |
| Affiliation |
Shyam Shah Medical College |
| Address |
Dept of Pediatrics,Shyam Shah Medical College,Rewa
MADHYA PRADESH
486001
India |
| Phone |
9399372171 |
| Fax |
|
| Email |
naresh30405@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics,Gandhi Memorial Hospital,Shyam Shah Medical College,Rewa
(486001).Madhya Pradesh,India |
|
|
Primary Sponsor
|
| Name |
Borkar Shankar Dattatray |
| Address |
Junior Resident,Department of Pediatrics,Shyam Shah Medical College,Rewa, Madhya Pradesh, India. Pin 486001 |
| 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 |
| Dr Borkar Shankar Dattatray |
Gandhi Memorial Hospital |
Department of Pediatrics,Shyam Shah Medical College,Rewa(486001),MP
Rewa
MADHYA PRADESH |
9545789413
borkarshankar7781@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shyam Shah Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P84||Other problems with newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Umbilical cord blood transfusion |
20 ml/kg in preterms for 4 hours |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
1.Neonates born earlier than 37 weeks requiring blood transfusion.
2.Patient attender agree with consent form |
|
| ExclusionCriteria |
| Details |
1.Patients with major congenital malformation incompatible with life.
2.Patient previously transfused with blood. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hematocrit and hemoglobin levels |
After 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Need for repeat transfusion
Need for Erythropoietin injection
weight gain velocity
sepsis evidence
outcome |
After 72 hours |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/05/2025 |
| 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
|
Preterm infants admitted in our institute will be divided into 2 groups.Umblical cord blood will be collected with aseptic technique from uncomplicated vaginal/LSCS deliveries.The availability of Umbilical cord blood in our blood bank will be assessed.The response and complications rates will be compared. |