| CTRI Number |
CTRI/2024/04/065454 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
06/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Blood] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare thinner blood(with 40% Red Blood Cell) versus thicker blood(with 60% Red Blood Cell) during exchange transfusion in Rh negative pregnancy |
|
Scientific Title of Study
|
Comparison of reconstituted blood with 40 ± 5% versus 60 ± 5% hematocrit for double volume exchange transfusion in neonates with hemolytic disease of the newborn: a randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rudresh Naik M R |
| Designation |
Senior Resident |
| Affiliation |
AIl India Institute of Medical Sciences, New Delhi |
| Address |
Room no 801, C wing, 8th floor, Mother and Child block, Division of Neonatology, Department of Pediatrics, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
8867300464 |
| Fax |
|
| Email |
rudreshnaik3210@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anu Sachdeva |
| Designation |
Additional Professor |
| Affiliation |
AIl India Institute of Medical Sciences, New Delhi |
| Address |
Room no 801, C wing, 8th floor, Mother and Child block, Division of Neonatology, Department of Pediatrics, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9891392188 |
| Fax |
|
| Email |
dranuthukral@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rudresh Naik M R |
| Designation |
Senior Resident |
| Affiliation |
AIl India Institute of Medical Sciences, New Delhi |
| Address |
Room no 801, C wing, 8th floor, Mother and Child block, Division of Neonatology, Department of Pediatrics, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
8867300464 |
| Fax |
|
| Email |
rudreshnaik3210@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, New Delhi |
| Address |
Ansari Nagar East, New Delhi |
| 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 Anu Sachdeva |
All India Institute of Medical sciences, New Delhi |
Room no 801, C wing, 8th floor, Mother and Child block, Division of Neonatology, Department of Pediatrics, AIIMS, New Delhi
South
DELHI |
9891392188
dranuthukral@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research, All India Institute of Medical Sciences, Ansari Nagar, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P550||Rh isoimmunization of newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Double volume exchange transfusion with 40 ± 5% hematocrit |
All neonates with Rh isoimmunization will be screened for enrolment. The parents will be approached for consent after applying the inclusion and exclusion criteria. If consented, the resident on duty will pick a sealed envelope with an allocation of (40±5%) haematocrit for exchange transfusion. Venepuncture samples will be taken for total serum bilirubin estimation before and after double volume exchange transfusion to monitor and decide on the duration of phototherapy. The duration of intervention will be the length of the stay of the baby in the hospital. |
| Comparator Agent |
Double volume exchange transfusion with 60 ± 5% hematocrit |
All neonates with Rh isoimmunization will be screened for enrolment. The parents will be approached for consent after applying the inclusion and exclusion criteria. If consented, the resident on duty will pick a sealed envelope with an allocation of (60±5%) haematocrit for exchange transfusion. Venepuncture samples will be taken for total serum bilirubin estimation before and after double volume exchange transfusion to monitor and decide on the duration of phototherapy. The duration of observation will be the length of the stay of the baby in the hospital. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All live neonates with diagnosed Rh isoimmunization and requiring DVET will be eligible for the study.
|
|
| ExclusionCriteria |
| Details |
Major malformations |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the duration of phototherapy in neonates requiring DVET with reconstituted Blood of lower haematocrit (40 ± 5%) in comparison to that with a higher haematocrit (60 ± 5%) |
28 days of life (After DVET till discharge from hospital)which is the neonatal period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the post-exchange serum bilirubin in the two groups at 0, 6 & 12 hours |
At 0, 6, & 12 hours after completion of DVET |
| To compare the number of DVET per neonate between the two groups |
Till discharge after birth admission |
| To compare the number of packed cell transfusions post DVET between the two groups till 12 weeks |
Till 12 weeks of postnatal age |
| To compare the duration of hospital stay between the two groups |
Birth to discharge after birth admission |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
18/04/2024 |
| 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="1"
Months="9"
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
|
All neonates with Rh isoimmunization will be screened for enrolment. The parents will be approached for consent after applying the inclusion and exclusion criteria. If consented, the resident on duty will pick a sealed envelope with an allocation of (40±5%) or (60±5%) haematocrit for exchange transfusion. Venepuncture samples will be taken for total serum bilirubin estimation before and after double volume exchange transfusion to monitor and decide on the duration of phototherapy. |