| CTRI Number |
CTRI/2019/11/021886 [Registered on: 06/11/2019] Trial Registered Prospectively |
| Last Modified On: |
04/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Umbilical cord blood collected from term babies for transfusion in premature babies |
|
Scientific Title of Study
|
Allogeneic umbilical cord blood for red cell concentrates (RCC) transfusion in preterm
infants - An exploratory clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Thangaraj Abiramalatha |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research Porur, Chennai |
| Address |
Department of Neonatology
Sri Ramachandra Institute of Higher Education and Research
Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9840857407 |
| Fax |
|
| Email |
abi_paeds@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Thangaraj Abiramalatha |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research Porur, Chennai |
| Address |
Department of Neonatology
Sri Ramachandra Institute of Higher Education and Research
Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9840857407 |
| Fax |
|
| Email |
abi_paeds@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Thangaraj Abiramalatha |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research Porur, Chennai |
| Address |
Department of Neonatology
Sri Ramachandra Institute of Higher Education and Research
Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9840857407 |
| Fax |
|
| Email |
abi_paeds@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Intramural GATE Research fund, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai-600116, Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Intramural GATE Research fund from SRIHER |
| Address |
Sri Ramachandra Institute of Higher Education and Research (SRIHER)
Porur, Chennai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Thangaraj Abiramalatha |
Sri Ramachandra Institute of Higher Education and Research |
Department of Neonatology
Sri Ramachandra Institute of Higher Education and Research
Porur, Chennai
Chennai
TAMIL NADU |
9840857407
abi_paeds@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D648||Other specified anemias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Allogeneic umbilical cord blood for transfusion in preterm neonates |
Allogeneic umbilical cord blood will be collected from well term neonates born by elective caesarean delivery, processed and stored in the blood bank. It will be used for transfusion in preterm neonates after checking quality parameters and cross-matching. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
1. For collection of UCB - Term (≥37 weeks gestation) infants delivered by elective caesarean section
2. For transfusion of UCB - Premature infants <1500 g birth weight requiring transfusion during the NICU stay |
|
| ExclusionCriteria |
| Details |
For collection of UCB
1. Mothers positive for HIV, HBsAg, HCV or VDRL
2. Mothers positive for unusual RBC antibodies screen
3. Mother who opt for cord blood banking
4. Maternal-fetal iso-immunization
5. Lack of consent
For transfusion of UCB
1. UCB compatible with baby’s blood not available
2. Lack of consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of red cell concentrates (RCC) transfusions in preterm infants that are covered by UCB |
Until discharge from the NICU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Success rate of UCB collection after DCC (defined as absolute UCB volume ≥ 25 mL)
2. Volume of UCB collected/volume of RCC obtained
3. Proportion of UCB units with satisfactory quality based on microbiological, hematological
and biochemical parameters available until 21 days of storage. |
21 days of storage (maximum) |
|
|
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 3 |
|
Date of First Enrollment (India)
|
01/12/2019 |
| 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
|
The objective of the study is to assess the feasibility and safety of collection, storage and clinical use of allogeneic umbilical cord blood (UCB) for red cell concentrates (RCC) transfusion in preterm infants. UCB will be collected from term neonates born by elective caesarean section using the cord blood collection kit. RCC will be separated from UCB and stored in the blood bank at 2-6’C. Quality parameters namely, blood culture, screen for transfusion transmitted infections, biochemical and haematological parameters will be done in UCB-RCC at weekly intervals. For preterm infants <1500 g birth weight requiring transfusion during NICU stay, RCC from UCB will be used after cross-matching and irradiation.
|