| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- 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.
- 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.
- 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. |