| CTRI Number |
CTRI/2020/04/024701 [Registered on: 17/04/2020] Trial Registered Prospectively |
| Last Modified On: |
07/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [blood transfusion] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Usefulness umbilical cord blood transfusion in neonates |
|
Scientific Title of Study
|
To study the effectiveness of umbilical cord blood transfusion in neonates at tertiary health care centre |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shoaib Beg Mirza |
| Designation |
Resident Medical Officer |
| Affiliation |
SS Medical College |
| Address |
Department of Pediatrics
Gandhi memorial hospital
SS Medical College
Rewa
MADHYA PRADESH
486001
India |
| Phone |
7869918636 |
| Fax |
|
| Email |
shoaibbegmirza@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shoaib Beg mirza |
| Designation |
Resident Medical Officer |
| Affiliation |
SS Medical College |
| Address |
Department of Pediatrics
Gandhi memorial hospital
SS Medical College
Rewa
MADHYA PRADESH
486001
India |
| Phone |
7869918636 |
| Fax |
|
| Email |
shoaibbegmirza@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak dwivedi |
| Designation |
Associate Professor |
| Affiliation |
SS Medical College |
| Address |
Department of Pediatrics
Gandhi memorial hospital
SS Medical College
Rewa
MADHYA PRADESH
486001
India |
| Phone |
7869918636 |
| Fax |
|
| Email |
deepakdwi72@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SS Medical College |
| Address |
Gandhi memorial hospital
SS Medical college |
| Type of Sponsor |
Government medical college |
|
|
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 Deepak Dwivedi |
Gandhi Memorial Hospital |
special newborn care unit Department of Pediatrics
SS Medical College
Rewa
MADHYA PRADESH |
07869918636
deepakdwi72@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee SS Medical College |
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 whole blood |
those newborn requiring blood transfusion were transfused with whole adult blood |
| Intervention |
umblical cord whole blood. |
those neonates requiring blood transfusion were transfused with umibilical cord blood |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
1. Neonates >34 week gestation admitted in NICU requiring Blood Transfusion & whose parents gave legal consent for the procedure. |
|
| ExclusionCriteria |
| Details |
1.Patient who were not willing for the procedure.
2. Neonates who have earlier h/o blood transfusion.
3. Syndromic Neonates and those with Congenital Anomaly.
4. Neonates with hemolytic disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
mortality of subjects
appearance of side effects |
Appearance of side effects : at the time of tranfusion
1 hour after transfusion
2 hour after transfusion
Mortality of subjects: at the time of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| usefulness of umblical cord blood transfusion in neonatal care |
from admission in nicu to discharge. |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/04/2020 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Objective: To determine the usefulness
of umbilical cord blood (UCB) as an alternative to adult blood (AB) in neonates
and to compare change in haematological parameters after transfusion &
compare outcomes. Study design: It was an interventional study of UCB transfusions
given to neonates requiring blood. UCB was collected in labour Room, under all
aseptic precautions, and pretesting were done in blood bank. Neonates fulfilling inclusion criteria were included. UCB
and AB was given as per availability and consent. Post blood analysis was done
after 6 hours of transfusion, watched for reactions. Outcomes like death,
discharge and duration of hospital stay were analysed. Results: A total of 91 blood transfusion were performed, out of which 34 received
UCB and 57 with AB. Mean rise of haemoglobin in UCB transfused patient was
2.01gm/dl. Conclusion: In neonates requiring blood
transfusion whole UCB is a good and safe alternative of whole AB. |