| CTRI Number |
CTRI/2024/11/077192 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
15/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Other |
|
Public Title of Study
|
Exploring the possibility of Umbilical Cord Blood Transfusions for Preterm Infants Following Delayed Cord Clamping |
|
Scientific Title of Study
|
Feasibility of umbilical cord blood transfusion in preterm infants after delayed cord clamping |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrPoorna OviaA |
| Designation |
PG student |
| Affiliation |
Prashanth hospitals |
| Address |
NICU,Department of paediatrics,second floor, Old block
Prashanth Super Speciality Hospitals,
36 & 36A Velachery main road,Velachery Chennai
Chennai
TAMIL NADU
600042
India |
| Phone |
9940417287 |
| Fax |
|
| Email |
poornaovia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPrakashV |
| Designation |
HOD, department of Paediatrics |
| Affiliation |
Prashanth Hospitals |
| Address |
Room no 103, consultancy room first floor,old block,Prashanth Super Speciality Hospitals,
36 & 36A Velachery main road,Velachery Chennai
Chennai
TAMIL NADU
600042
India |
| Phone |
9968857025 |
| Fax |
|
| Email |
dr_praky76@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrPrakashV |
| Designation |
HOD, department of Paediatrics |
| Affiliation |
Prashanth Hospitals |
| Address |
room no 103, consultant room, first floor,old block,
Prashanth Super Speciality Hospitals,
36 & 36A Velachery main road,Velachery Chennai
Chennai
TAMIL NADU
600042
India |
| Phone |
9968857025 |
| Fax |
|
| Email |
dr_praky76@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Prashanth super speciality hosptal, 36 & 36A Velachery, main road, Velachery, Chennai ,Tamil nadu, India
pin 600042 |
|
|
Primary Sponsor
|
| Name |
DrPoorna ovia |
| Address |
NICU,department of Paediatrics, old block,Prashanth Super Speciality Hospitals,
36 & 36A Velachery main road,Dhandeeswaram,Velachery Chennai |
| 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 |
| DrPoorna oviaA |
Prashanth super speciality Hospitals |
NICU,Paediatrics department,second floor old block
36 & 36A Velachery main road,Dhandeeswaram,Velachery Chennai
Chennai
TAMIL NADU |
9940417287
poornaovia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chennai Meenakshi Multispeciality Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
cord blood from delivering mothers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
preterm babies less than or equal to 30 weeks
or estimated fetal weight less than 1200 grams
born by vaginal or caesarean section who consented before delivery |
|
| ExclusionCriteria |
| Details |
Clinical Chorioamnionitis
Mother HIV positive
Mother HbsAg positive
Mother HBc Ag positive
Rh isoimmunization
Antenatally detected Major congenital anomalies
Delayed cord clamping of 30 sec not possible due to the neonatal condition |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Success rate of umbilical cord blood collection more than 15ml per kg body weight after deleayed cord clamping.
|
30 seconds after birth. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of umbilical cord blood units with satisfactory microbiological , haematological and biochemical quality available until 21 days of storage |
2 years |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
26/11/2024 |
| 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="2"
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
|
HYPOTHESIS:Can we collect adequate amount of umbilical cord blood ( > 15ml/kg) after delayed cord clamping of 30 seconds among preterm neonates less than or equal to 30 weeks gestation or having estimated weight of less than 1200 grams and to check the quality of blood for transfusion till 21 days post collection,
JUSTIFICATION:Very low birth weight more so for extreme low birth weight babies require blood transfusion during NICU stay. the adult blood used for transfusion has less fetal hemoglobin and risk for oxidative stress and immunological reactions when compared to neonatal blood, if we are able to collect and store baby blood after delayed cord clamping and use it in the same baby, baby gets advantage of lesser transfusion related reactions.
BACKGROUND:Though studies have evaluated the safety of umbilical cord blood transfusins in preterm infants , the clinical use of autologous transfusion is limited and these trials have collected cord blood immediatly after cord clamping.
hence in this study we aim to assess the feasibility of umbilical cord blood collection after delayed cord clamping among extreme preterm and to asses the quality of collected blood for autologous transfusion in these infants.
|