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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  
Name  Address 
NIL  NA 
 
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  
Status 
Not Applicable 
 
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.

 
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