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Comparision Of Safety and Efficacy Of Standard Volume vs High Volume Blood Transfusion in Preterm Neonates less than 32 weeks - A Randomised Controlled Trial

Comparision Of Safety and Efficacy Of Standard Volume (15-20ml/kg) vs High Volume (25-30ml/kg) PRBC Transfusion in Preterm Neonates less than 32 weeks - A Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078680
Enrollment
90
Registered
2024-12-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: - Health Condition 2: P612- Anemia of prematurity

Interventions

Intervention1: High volume vs Low volume Blood transfusion: To study the safety and the efficacy of high volume versus low volume blood transfusion Intervention2: High volume blood transfusion: 25-30

Sponsors

Vineetha Prasad Nannapaneni
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All neonates with gestational age less than 32 weeks requiring blood transfusion after 1 week of life

Exclusion criteria

Exclusion criteria: Hemodynamically significant patent ductus arteriosus, congestive cardiac failure , Necrotizing enterocolitis stage 2 or higher Congenital heart defects Hemodynamic instability – Shock with Inotropic Support Symptomatic Intraventricular hemorrhage – catastrophic and saltatory High Ventilatory Support ,with labile saturations Fluid Overload - excessive weight gain ,decreased urine output ,edema , hepatomegaly , tachypnea Severe Bronchopulmonary Dysplasia with features of Pulmonary Hypertension.

Design outcomes

Primary

MeasureTime frame
Number of subsequent transfusions required in higher volume versus lower volume blood transfusion in preterm infants requiring blood transfusionTimepoint: day 7 till discharge—

Secondary

MeasureTime frame
Hemoglobin 3-7 days post transfusion , total volume of transfused blood , time to subsequent transfusion , length of hospital stay , mortality , sepsis , transfusion reactions , Fluid overload , cardiac dysfunction , Retinopathy of prematurity , Bronchopulmonary dysplasia , , patent ductus arteriosus , necrotizing enterocolitis , intraventricular hemorrhage , hyperkalemia , iron status at dischargeTimepoint: Day 7 till discharge—

Countries

India

Contacts

Public ContactDr Giridhar Sethuraman

Chettinad Hospital and research institute

giridharsethu@gmail.com9841027228

Outcome results

None listed

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