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CTRI Number  CTRI/2025/11/098141 [Registered on: 27/11/2025] Trial Registered Prospectively
Last Modified On: 26/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of injection Darbepoetin in reducing the need of blood transfusion in babies born to mothers with RH negative blood group. 
Scientific Title of Study   Efficacy of Darbepoetin alpha in reducing the need for top-up transfusions in neonates born at more than or equal to 34 weeks of gestation with Rh isoimmunisation treated with intrauterine transfusion: a Randomised control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shivangi Sinha 
Designation  Junior Resident 
Affiliation  AIl India Institute of Medical Sciences, New Delhi 
Address  Newborn Health and Knowledge Centre, first floor, Division of Neonatology, Department of Paediatrics, AIIMS New Delhi

South
DELHI
110029
India 
Phone  7488389889  
Fax    
Email  sinha.shivangi@ymail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ankit Verma 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Newborn Health and Knowledge Centre, first floor, Division of Neonatology, Department of Paediatrics, AIIMS New Delhi

South
DELHI
110029
India 
Phone  8447343609  
Fax    
Email  ankitverma0486@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shivangi Sinha 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Newborn Health and Knowledge Centre, first floor, Division of Neonatology, Department of Paediatrics, AIIMS New Delhi

South
DELHI
110029
India 
Phone  7488389889  
Fax    
Email  sinha.shivangi@ymail.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  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shivangi Sinha  All India Institute of Medical Sciences, New Delhi  Division of Neonatology, Department of Pediatrics, 8th floor, Mother and Child Block, AIIMS
South
DELHI 
7488389889

sinha.shivangi@ymail.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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P550||Rh isoimmunization of newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Darbepoetin alpha   Darbepoetin alpha (at 10 mcg/kg subcutaneously weekly) will be administered to the neonates born at more than or equal to 34 weeks with Rh isoimmunisation and treated with intrauterine transfusions for a total of 4 weeks (if the haemoglobin at the end of 4 weeks is more than 13 g/dL) or until 8 weeks (if the haemoglobin at the end of 4 weeks is less than 13 g/dL) in addition to standard care (phototherapy, exchange transfusion, folic acid) 
Comparator Agent  Standard care   Standard care (phototherapy, exchange transfusion, folic acid) 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  8.00 Day(s)
Gender  Both 
Details  Neonates born at more than or equal to 34 weeks of gestation with
Rh isoimmunisation
Who have received at least one intrauterine transfusion
 
 
ExclusionCriteria 
Details  Congenital anomalies and chromosomal malformations
Known case of neonatal hypertension
Infants with seizure disorder
Infants with thrombotic diseases
Patients with other known causes of anaemia, like G6PD deficiency or coagulopathies
Inability to follow up 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Number of top-up transfusions received by neonates born at more than or equal to 34 weeks of gestation with Rh isoimmunisation between 7 days to 3 months of life.  At the end of 3 months of postnatal age 
 
Secondary Outcome  
Outcome  TimePoints 
Haemoglobin levels  At 30 (23-37) days, 60 (53-67) days and 90 (83-97) days of postnatal age 
Hemolysis on peripheral smear  At 30 (23-37) days, 60 (53-67) days and 90 (83-97) days of postnatal age 
Reticulocyte count  At 30 (23-37) days, 60 (53-67) days and 90 (83-97) days of postnatal age 
Ferritin levels  At 90 (83-97) days of postnatal age 
Noninvasive blood pressure  At 30 (23-37) days, 60 (53-67) days and 90 (83-97) days of postnatal age 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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 3 
Date of First Enrollment (India)   07/12/2025 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  Proposals should be directed to Dr Ankit Verma (email: ankitverma0486@gmail.com). Data access would be provided upon reasonable request after signing a data access agreement.

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This open-label randomized controlled trial aims to evaluate the efficacy of darbepoetin alpha in reducing top-up packed red blood cell (PRBC) transfusion requirements in neonates born at more than or equal to 34 weeks of gestation with Rh isoimmunization who have received one or more intrauterine transfusions. Eligible neonates will be screened on Day 7 (Day 6-Day 8) of life and, after consent, will be randomized to receive either darbepoetin alpha (10 mcg/kg/week subcutaneously) for 4 weeks (if hemoglobin at the end of 4 weeks is more than 13 g/dL) or until 8 weeks (if hemoglobin at the end of 4 weeks is less than 13 g/dL) in addition to standard care (intervention group) or standard care alone (phototherapy, exchange transfusion, folic acid) (control group). The primary objective is to assess reduction in packed red blood cell transfusions between Day 7 and 3 months of age. Secondary objectives include comparison of hemoglobin levels, reticulocyte counts, serum ferritin, peripheral smear findings (for evidence of hemolysis), and blood pressure recordings. Baseline investigations include serum erythropoietin, reticulocyte count, and hemoglobin. The study will enroll 56 neonates and be conducted at AIIMS New Delhi’s NICU, postnatal ward, and high-risk clinic. This trial addresses a critical evidence gap by focusing specifically on Rh isoimmunized neonates, a population frequently requiring multiple transfusions due to late-onset hypoproliferative anemia, particularly in resource-limited settings. Findings will provide valuable insights into erythropoiesis-stimulating agent (ESA) use in hemolytic disease of the fetus and newborn due to Rh incompatibility.

 
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