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Studying the advantage of albumin(protein) treatment prior to blood exchange in newborn babies with severe jaundice

EFFICACY OF PRE- EXCHANGE ALBUMIN PRIMING IN REDUCING THE PHOTOTHERAPY DURATION IN HEALTHY TERM AND LATE PRETERM INFANTS WITH SIGNIFICANT HYPERBILIRUBINEMIA: A RANDOMIZED, BLINDED, PLACEBO CONTROLLED TRIAL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/03/002530
Enrollment
50
Registered
2012-03-28
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- neonates with significant hyperbilirubinemia

Interventions

Intervention1: 20% human albumin: 20% human albumin 1g/kg infused intravenously over 1 hour. Duration of therapy - one hour Control Intervention1: Normal saline: Normal saline 5ml/kg infused intraveno

Sponsors

Postgraduate Institute of Medical Education and Research PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy neonates of gestational age >34wks with hyperbilirubinemia admitted in the newborn unit for blood exchange transfusion.

Exclusion criteria

Exclusion criteria: •Small for gestational age neonates •Neonates who are sick and are hemodynamically unstable •Neonates with features of hydrops or edema •Neonates with proven hemolytic disease •Neonates with suspected or proven conjugated hyperbilirubinemia •Neonates with low haematocrit •Neonates with features of acute bilirubin encephalopathy at admission where urgent BET is a priority •Life threatening congenital malformations •Neonates with features of volume overload •Parents not willing to participate in the study and hence refused consent

Design outcomes

Primary

MeasureTime frame
Duration of phototherapy (in hours) following Blood Exchange TransfusionTimepoint: Time at End of BET to time at stopping of phototherapy—

Secondary

MeasureTime frame
â?¢Total amount of bilirubin removed following BET â?¢Total serum bilirubin immediately following BET â?¢Need for repeat BET(s) â?¢Post BET TSB levels at 2, 6, 12 and 24 hours Timepoint: End of BET, 2, 6 12, 24 hours following BET and 12 hourly till stopping phototherapy—

Countries

India

Contacts

Public ContactDr Praveen kumar

PGIMER

drpkumarpgi@gmail.com9463200068

Outcome results

None listed

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