Role of injection Darbepoetin in reducing the need of blood transfusion in babies born to mothers with RH negative blood group.

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/098141

Enrollment

Registered

2025-11-27

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P550- Rh isoimmunization of newborn

Interventions

Intervention1: 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

Eligibility

Inclusion criteria

Inclusion criteria: Neonates born at more than or equal to 34 weeks of gestation with Rh isoimmunisation Who have received at least one intrauterine transfusion

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.Timepoint: At the end of 3 months of postnatal age	—

Secondary

Measure	Time frame
Haemoglobin levelsTimepoint: At 30 (23-37) days, 60 (53-67) days and 90 (83-97) days of postnatal age;Hemolysis on peripheral smearTimepoint: At 30 (23-37) days, 60 (53-67) days and 90 (83-97) days of postnatal age;Reticulocyte countTimepoint: At 30 (23-37) days, 60 (53-67) days and 90 (83-97) days of postnatal age;Ferritin levelsTimepoint: At 90 (83-97) days of postnatal age;Noninvasive blood pressureTimepoint: At 30 (23-37) days, 60 (53-67) days and 90 (83-97) days of postnatal age	—

Measure

Time frame

Haemoglobin levelsTimepoint: At 30 (23-37) days, 60 (53-67) days and 90 (83-97) days of postnatal age;Hemolysis on peripheral smearTimepoint: At 30 (23-37) days, 60 (53-67) days and 90 (83-97) days of postnatal age;Reticulocyte countTimepoint: At 30 (23-37) days, 60 (53-67) days and 90 (83-97) days of postnatal age;Ferritin levelsTimepoint: At 90 (83-97) days of postnatal age;Noninvasive blood pressureTimepoint: At 30 (23-37) days, 60 (53-67) days and 90 (83-97) days of postnatal age

—

Countries

India

Contacts

Public ContactShivangi Sinha

All India Institute of Medical Sciences, New Delhi

ankitverma0486@gmail.com8447343609

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026