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Clinical monitoring based bilirubin assessment versus routine bilirubin assessment in neonates with ABO incompatibility

Clinical monitoring based bilirubin assessment versus routine bilirubin assessment in neonates with ABO incompatibility.A randomized controlled trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078712
Enrollment
114
Registered
2024-12-30
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

None listed

Interventions

Intervention1: visually assessed for jaundice every 12 hours: Neonates will be visually assessed for jaundice every 12 hours following delivery until discharge. Total serum bilirubin should be measur

Sponsors

Ameyaarjun Arumugam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Newborn babies =35 weeks of gestation who are direct coomb’s test positive at birth due to ABO incompatibility

Exclusion criteria

Exclusion criteria: 1.Neonates less than 35 weeks gestation , Neonates with major congenital malformations or syndromic features,Neonates who require extensive resuscitation at birth,Neonates who require immediate NICU stay with advanced life support, Neonates who have features of hydrops fetalis on antenatal scans & required Intrauterine Transfusions, Neonates whose parents haven’t given consent for including in the study ,Neonates with perinatal asphyxia,acute cord vascular accident,Severe SGA neonates

Design outcomes

Primary

MeasureTime frame
Need for phototherapyTimepoint: 1 year

Secondary

MeasureTime frame
Neonates with sepsis Timepoint: 1 year;Neonates with peak bilirubin levels reaching close to exchange transfusion zoneTimepoint: 1 year;Total duration of phototherapyTimepoint: 1 year;Neonates requiring IVIG therapyTimepoint: 1 year;Neonates requiring exchange transfusionTimepoint: 1 year;Length of hospital stayTimepoint: 1 year;Rebound hyperbilirubinemia in neonates treated with phototherapyTimepoint: 1 year;Readmission to hospitalTimepoint: 1 year

Countries

India

Contacts

Public ContactGiridhar S

Chettinad Hospital and Research Institute

giridharsethu@gmail.com9841027228

Outcome results

None listed

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