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Comparison of Two Methods to Guide Partial Exchange Transfusion in Small for Gestational Age Newborn Babies with Polycythemia

Success of Partial Exchange in Term Small For Gestational Age Polycythemic Neonates Using a Revised Blood-Volume Estimate (Rawlings X 1.2) vs Conventional Rawlings-Based Calculation: A Randomized controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/106300
Enrollment
48
Registered
2026-03-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: D758- Other specified diseases of bloodand blood-forming organs

Interventions

Intervention1: Blood volume for partial exchange transfusion calculation by Rawlings 1point 2: In the intervention group the exchange volume will be calculated using the modified blood volume estimat

Sponsors

Lok Nayak Hospital, Maulana Azad Medical
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Term neonates more than or equal to 37 weeks gestation Small for gestational age Birth weight less than 10th percentile as per standard growth charts Intergrowth-21st Indication for Partial Exchange Transfusion Venous hematocrit more than or equal to 65 percent with clinical symptoms OR Venous hematocrit more than or equal to 75 percent in asymptomatic neonates

Exclusion criteria

Exclusion criteria: Major congenital anomalies or chromosomal disorders Perinatal asphyxia requiring ongoing intensive support Suspected or confirmed twin-to-twin transfusion syndrome with hemodynamic instability Severe dehydration or shock not corrected prior to PET

Design outcomes

Primary

MeasureTime frame
Success rate (proportion) of achieving target post-exchange venous hematocrit (50 55%) at 60 15 minutes post-PET.Timepoint: Success rate (proportion) of achieving target post-exchange venous hematocrit (50 55%) at 60 15 minutes post-PET.—

Secondary

MeasureTime frame
Proportion of neonates requiring repeat PET within 24 hours.Timepoint: 24 hours;2. Proportion and mean duration of sustained hematocrit control (50 55%) during 24-hour post-exchange monitoring.Timepoint: 24 hours;Incidence and type of PET-related complications within 24 hours.Timepoint: 24 hours;Incidence of sepsis within 72 hours post-PET.Timepoint: 72 hours;5. Mean difference and agreement analysis of calculated blood and exchange volumes among three formulae (Rawlings, SGA-adjusted, and 50th-percentile substitution).Timepoint: At the begining of starting the procedure—

Countries

India

Contacts

Public ContactGarvita Srivastava

Maulana Azad Medical College

neoashish2008@gmail.com9810694789

Outcome results

None listed

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