A clinical trial to study role of exchange transfusion in severe neonatal sepsis

Double volume exchange transfusion in severe neonatal sepsis: A Randomised Controlled Trial

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/09/003014

Enrollment

Registered

2012-09-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- severe neonatal sepsis

Interventions

Intervention1: double volume exchange transfusion: Eligible neonates are randomised into exchange or no exchange group based on sequentially numbered opaque envelopes.In this arm child will receive do

Eligibility

Inclusion criteria

Inclusion criteria: >1kg, neonates with severe sepsis

Exclusion criteria

Exclusion criteria: gasping/moribund/life threatening congenital malformation/ hypotensive shock requiring >2 inotropes/ significant non mucosal clinical bleed/ platelets <20000

Design outcomes

Primary

Measure	Time frame
SurvivalTimepoint: 0-14 days from enrolment	—

Secondary

Measure	Time frame
Change ion immunoglobulin(IgG,IgA,IgM), Complement(C3),ANC before and after interventionTimepoint: before and after intervention;Complications following exchange transfusionTimepoint: 0-2days;normalisation/persistence/worsening of organ dysfunctionTimepoint: 0-14 days from enrolment;survivalTimepoint: 0-6hrs from enrolment	—

Countries

India

Contacts

Public ContactDr Praveen Kumar

PGIMER

venkatpgi@gmail.com9478001129

Outcome results

None listed

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