| CTRI Number |
CTRI/2024/08/072811 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
20/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The efficacy of two different doses of red blood cell transfusion in preterm babies. |
|
Scientific Title of Study
|
To evaluate the safety and effectiveness of packed red blood cell transfusions in two different doses in very low birth weight babies in neonatal intensive care unit. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahaveer Singh Lakra |
| Designation |
Assistant professor |
| Affiliation |
JNMC,Datta Meghe Institute of higher education and Research, Sawangi Meghe, Wardha,Maharashtra |
| Address |
Assistant professor, Department of Pediatrics, Jawaharlal Nehru Medical College
Datta Meghe Institute of higher education and Research, Sawangi Meghe, Wardha,Maharashtra.
Wardha MAHARASHTRA 442001 India |
| Phone |
9992693363 |
| Fax |
|
| Email |
lakra.mahaveer@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Amar Taksande |
| Designation |
Professor and HOD, Department of pediatrics. |
| Affiliation |
JNMC, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha,Maharashtra |
| Address |
Head of department, Department of Pediatrics. JNMC,DMIHER, Sawangi Meghe. Wardha, Maharashtra Head of department, Department of Pediatrics. JNMC,DMIHER, Sawangi Meghe. Wardha, Maharashtra Wardha MAHARASHTRA 442001 India |
| Phone |
9822369233 |
| Fax |
- |
| Email |
amar.taksande@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Amar Taksande |
| Designation |
Professor and HOD, Department of pediatrics. |
| Affiliation |
JNMC,Datta Meghe Institute of higher education and Research, Sawangi Meghe, Wardha,Maharashtra |
| Address |
Department of pediatrics. JNMC, DMIHER, Sawangi Meghe, Wardha, Maharashtra Not Applicable Wardha MAHARASHTRA 442001 India |
| Phone |
9822369233 |
| Fax |
- |
| Email |
amar.taksande@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of higher education and Research, Sawangi Meghe, Wardha,Maharashtra 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha,Maharashtra |
| Address |
Sawangi Meghe Wardha, Maharashtra .442001 |
| Type of Sponsor |
Private 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 Mahaveer Singh Lakra |
Acharya Vinoba bhave Rural Hospital |
Department of neonatology, Room No 2, Assistant professor chamber,Sawangi Meghe, Wardha MAHARASHTRA |
9992693363 - lakra.mahaveer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DMIMS (DU) Institutional ethical committee of DMIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D539||Nutritional anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Packed red blood cell (PRBC) transfusions.
|
PRBC transfusion in dose of 10 ml/kg body weight
Intravenous route
Frequency: Single dose
Duration of therapy: slowly Over 4 hours |
| Comparator Agent |
Packed red blood cells transfusion |
PRBC transfusion 20 ml/kg body weight
Route of administration : Intravenous
Duration : Over 4 hours
Frequency : Single aliquote
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
All babies requring PRC transfusion weighing less than 1500 gram.
All preterm and IUGR babies needing PRC transfusion in NICU
Babies receiving PRC for any of the reasons. |
|
| ExclusionCriteria |
| Details |
1. Babies with birth weight more than 1500 gm and less than 500 gram.
2. Major congenital anomalies and Congenital heart defects
3. Patient undergone exchange transfusion.
4. Parent not giving consent and not willing to participate in study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• The primary outcome will be post transfusion change in haemoglobin and hematocrit in infants following both PRBC transfusion treatment sequences.
• The total stay in the hospital and outcome in form of death.
|
• Subject enrollment at the time of admission.
Administration of PBRC : 0 day
PRBC tolerance : 2 days
primary Outcome : 1 week
Tolerance and recovery: 4 week
Data collection: 4-8 months
analysis: 10 th month
Declaration of result: 12 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
number of stay of days
Number f patients developed NEC
Correction of Anemia |
Enrollent of subject - Day 1
PRBC Transfusion - baseline
Collection of blood sample- 24 hours
Assessing the risk : 1 week
Outcome in form of complication: 3 weeks
Secondary outcome of mortality : at the time of discharge 4-6 weeks
|
|
|
Target Sample Size
|
Total Sample Size="104" Sample Size from India="104"
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)
|
01/09/2024 |
| 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="6" 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
|
Background: Blood transfusion is one of the lifesaving modalities in low birth weight babies. The very low birth weight babies (VLBW) are the most common recipient of multiple blood transfusion units due to their immaturity and illness and they are more vulnerable to adverse effects because of physiological immaturity of organ system. The doses generally used for PRBC is 20 ml/kg as a single aliquot which s well tolerated. The doses of 10 ml/kg in two different aliquots also practised and equally effective but tolerability varies. . Objectives: To evaluate the safety and effectiveness of 20 mL/kg single aliquot vs 10 ml/kg of 2 aliquots of packed red cell transfusions in very low birth weight babies. Study design: This will be a randomized double blind control trial and will be conducted in 20 bedded NICU in AVBRH hospital,Sawangi Meghe rural Hospital, Maharashtra. The total sample size is 104 and duration is 18 months. The inclusion and exclusion criteria’s has been defined and patients will be recruited as per the criteria. Methodology and data analysis: Informed parental consent will be obtained for eligible patients and then each infant will be randomized, using a random number generator as decided by the computerised slip, to one of the two treatment sequences: one receiving 20 mL/kg transfusion and other 10 mL/kg , 2 aliquots , 24 hours apart. Vital signs will be monitored hourly during and up to 6 hours after transfusion. Haematocrit, haemoglobin, and red blood cell counts will also collected 1 hour before transfusion and for 3 hours after transfusion.The data’s will be entered in spread excel sheet. Mean and range of haemoglobin, haematocrit and other parameters will be calculated and compared between two methods. Mean in 2 groups will be calculated and compared using chi square test. P values will be calculated and P value >0.5 will be taken as significant. |