A Study Comparing Two Types of Blood Used in Treating Severe Jaundice in Newborn Babies

Comparing Lower hematocrit (40 percent) versus Standard (60 percent) Hematocrit of Reconstituted Blood for Double Volume Exchange Transfusion in management of Neonatal Unconjugated Hyperbilirubinemia: A Randomized Controlled Trial - LoHEx Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/086157

Enrollment

Registered

2025-05-02

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

Health Condition 1: P559- Hemolytic disease of newborn, unspecified Health Condition 2: P599- Neonatal jaundice, unspecified

Interventions

Intervention1: Lower hematocrit reconstituted blood: Double volume exchange transfusion with lower hematocrit (40 percent) reconstituted blood upon meeting the criteria for double volume exchange tran

Eligibility

Inclusion criteria

Inclusion criteria: All live-born neonates, whether inborn or outborn, with neonatal hyperbilirubinemia requiring double volume exchange transfusion (DVET) will be included.

Exclusion criteria

Exclusion criteria: Neonates with major congenital malformations will be excluded from the study.

Design outcomes

Primary

Measure	Time frame
% fall in bilirubin levels and bilirubin albumin ratio post double volume exchange transfusionTimepoint: 6 hours post completion of double volume exchange transfusion	—

Secondary

Measure	Time frame
% fall in bilirubin levels and bilirubin albumin ratio post double volume exchange transfusionTimepoint: 0,2,12,24 hours post completion of double volume exchange transfusion;Duration of phototherapy between the two groups.Timepoint: At discharge;Number of double volume exchange transfusions requiredTimepoint: At discharge;Total duration of hospital stayTimepoint: At discharge;Need for additional transfusion post DVETTimepoint: At discharge;Brain stem evoked audiometry (BERA)Timepoint: At discharge or at followup;Incidence of anaemiaTimepoint: At 3 months age;Neurodevelopmental outcome with Bayley IVTimepoint: At 3 months of age	—

Measure

Time frame

% fall in bilirubin levels and bilirubin albumin ratio post double volume exchange transfusionTimepoint: 0,2,12,24 hours post completion of double volume exchange transfusion;Duration of phototherapy between the two groups.Timepoint: At discharge;Number of double volume exchange transfusions requiredTimepoint: At discharge;Total duration of hospital stayTimepoint: At discharge;Need for additional transfusion post DVETTimepoint: At discharge;Brain stem evoked audiometry (BERA)Timepoint: At discharge or at followup;Incidence of anaemiaTimepoint: At 3 months age;Neurodevelopmental outcome with Bayley IVTimepoint: At 3 months of age

—

Countries

India

Contacts

Public ContactWrik Laha

All India Institute of Medical Sciences, Jodhpur

drsusil85@gmail.com9013355932

Outcome results

None listed

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