| CTRI Number |
CTRI/2017/02/007924 [Registered on: 20/02/2017] Trial Registered Prospectively |
| Last Modified On: |
19/09/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Blood product] |
| Study Design |
Single Arm Trial |
|
Public Title of Study
|
Babys own umbilical cord blood for transfusion in premature newborn babies |
Scientific Title of Study
Modification(s)
|
Autologous umbilical cord blood for red cell concentrates (RCC) transfusion in preterm infants- An uncontrolled trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thangaraj Abiramalatha |
| Designation |
Senior resident |
| Affiliation |
Department of Neonatology, Sri Ramachandra University, Porur, Chennai |
| Address |
F-1/3, DABC, Aishwaryam phase-2
Nolambur
Chennai
Department of Neonatology,
Sri Ramachandra University,
Porur, Chennai-600116
Chennai
TAMIL NADU
600095
India |
| Phone |
9840857407 |
| Fax |
|
| Email |
abi_paeds@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Binu Ninan |
| Designation |
Professor and Head |
| Affiliation |
Department of Neonatology, Sri Ramachandra University, Porur, Chennai |
| Address |
No-31, Shanmugam flats,
Pari Street,
Mogappair East
Chennai
Department of Neonatology,
Sri Ramachandra University,
Porur, Chennai-600116
Chennai
TAMIL NADU
600037
India |
| Phone |
9841283832 |
| Fax |
|
| Email |
drbinusss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Thangaraj Abiramalatha |
| Designation |
Senior resident |
| Affiliation |
Department of Neonatology, Sri Ramachandra University, Porur, Chennai |
| Address |
F-1/3, DABC, Aishwaryam phase-2
Nolambur
Chennai
Department of Neonatology,
Sri Ramachandra University,
Porur, Chennai-600116
Chennai
TAMIL NADU
600095
India |
| Phone |
9840857407 |
| Fax |
|
| Email |
abi_paeds@yahoo.com |
|
|
Source of Monetary or Material Support
|
| GATE fund
Sri Ramachandra University, Porur, Chennai-600116 |
|
|
Primary Sponsor
|
| Name |
GATE fund Sri Ramachandra University |
| Address |
Sri Ramachandra University
Porur, Chennai-600116 |
| 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 |
| Thangaraj Abiramalatha |
Department of Neonatology, Sri Ramachandra University |
Department of Neonatology,
Sri Ramachandra University
Porur, Chennai-600116
Chennai
TAMIL NADU |
9840857407
abi_paeds@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
D759||Disease of blood and blood-formingorgans, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Autologous umbilical cord blood |
Autologous umbilical cord blood for red cell concentrates transfusion in preterm infants |
| Comparator Agent |
Nil |
Nil |
|
Inclusion Criteria
Modification(s)
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Premature infants <30 weeks gestational age and/or <1200g estimated fetal weight, who are delivered by vaginal delivery or caesarean section |
|
| ExclusionCriteria |
| Details |
Lack of consent
Mothers positive for HIV, HBsAg, HCV or VDRL
Clinical or proven chorioamnionitis
Mother who opt for cord blood banking
Major congenital anomalies or genetic syndromes
Maternal-fetal iso-immunization
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Number of Red cell concentrates transfusions from Umbilical cord blood |
Till 3 weeks of life |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
• Number of UCB units of adequate quantity (15ml/kg) and quality that could be collected
• Number of units of adequate quality (biochemical and hematological)
o On day 7
o On day 14
o On day 21
• Incidence of transfusion reactions
|
First 3 weeks of life |
|
|
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 2/ Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
01/05/2018 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
The trial will be published in an indexed, peer-reviewed journal |
Brief Summary
Modification(s)
|
Umbilical cord blood will be collected under strict aseptic precautions in both vaginal delivery and caesarean section. The collection bag will be transported to the blood bank immediately or stored at 2-6oC. In the blood bank, RCC will be separated from the UCB by refrigerated centrifugation at 1800 revolutions per minute (rpm) for 10 minutes. RCC will be stored at 2-6oC. Quality Indicators Blood culture (from the separated RCC)
Further at one-week interval · pH and lactate in blood gas analyzer · Biochemical - Potassium, glucose · Hematological o Complete blood count (CBC) - Hematocrit, mean corpuscular volume (MCV), platelet count, leucocyte count o Free plasma hemoglobin
Clinical use
UCB will be used only after confirming that the initial culture is sterile. |