To compare thinner blood(with 40% Red Blood Cell) versus thicker blood(with 60% Red Blood Cell) during exchange transfusion in Rh negative pregnancy

Comparison of reconstituted blood with 40 ± 5% versus 60 ± 5% hematocrit for double volume exchange transfusion in neonates with hemolytic disease of the newborn: a randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/065454

Enrollment

Registered

2024-04-09

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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: Double volume exchange transfusion with 40 ± 5% hematocrit: All neonates with Rh isoimmunization will be screened for enrolment. The parents will be approached for consent after applyin

Eligibility

Inclusion criteria

Inclusion criteria: All live neonates with diagnosed Rh isoimmunization and requiring DVET will be eligible for the study.

Exclusion criteria

Exclusion criteria: Major malformations

Design outcomes

Primary

Measure	Time frame
To determine the duration of phototherapy in neonates requiring DVET with reconstituted Blood of lower haematocrit (40 ± 5%) in comparison to that with a higher haematocrit (60 ± 5%)Timepoint: 28 days of life (After DVET till discharge from hospital)which is the neonatal period	—

Secondary

Measure	Time frame
To compare the duration of hospital stay between the two groupsTimepoint: Birth to discharge after birth admission;To compare the number of DVET per neonate between the two groupsTimepoint: Till discharge after birth admission;To compare the number of packed cell transfusions post DVET between the two groups till 12 weeksTimepoint: Till 12 weeks of postnatal age;To determine the post-exchange serum bilirubin in the two groups at 0, 6 & 12 hoursTimepoint: At 0, 6, & 12 hours after completion of DVET	—

Measure

Time frame

To compare the duration of hospital stay between the two groupsTimepoint: Birth to discharge after birth admission;To compare the number of DVET per neonate between the two groupsTimepoint: Till discharge after birth admission;To compare the number of packed cell transfusions post DVET between the two groups till 12 weeksTimepoint: Till 12 weeks of postnatal age;To determine the post-exchange serum bilirubin in the two groups at 0, 6 & 12 hoursTimepoint: At 0, 6, & 12 hours after completion of DVET

—

Countries

India

Contacts

Public ContactRudresh Naik M R

AIl India Institute of Medical Sciences, New Delhi

dranuthukral@gmail.com9891392188

Outcome results

None listed

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