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To find out the rise in hemoglobin and to study the effect of various factors on rise in hemoglobin after blood transfusion in newborn

Determinants of Efficacy of Packed Red Blood Cells Transfusion in Neonates

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2014/10/005094
Enrollment
110
Registered
2014-10-13
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 requiring PRBC transfusion

Interventions

None listed

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates (term up to 28 days of age and preterm up to corrected age of four weeks) admitted in Newborn unit requiring PRBC transfusion for anemia

Exclusion criteria

Exclusion criteria: • Life threatening congenital malformations • Neonates with immune hemolytic condition (defined as a positive Direct Coombâ??s test, exaggerated reticulocyte response or peripheral smear showing evidence of hemolysis) • Previous â??out of studyâ?? blood transfusions (neonates who have already received PRBC transfusion before being screened for the study) would be excluded. However neonates who have received blood transfusion previously as a part of study and require PRBC transfusion again would be eligible for inclusion. • Parents not willing to participate in the study and hence refused consent.

Design outcomes

Primary

MeasureTime frame
â?¢Percent rise in hematocrit at 15 minutes after PRBC transfusion.Timepoint: 15 min

Secondary

MeasureTime frame
â?¢ Percent rise in hematocrit at 6 hours after PRBC transfusion. â?¢ Factor affecting the rise of hematocrit â?¢ Percent rise in hematocrit at15 min, 6 hours and 24 hours of G6PD deficient PRBC transfusion â?¢ To study the evidence for hemolysis i.e, peripheral blood smear, reticulocyte count, plasma hemoglobin and rise in total serum bilirubin after 24 hours with G6PD deficient PRBC transfusion. Timepoint: 6 hour and 24 hours

Countries

India

Contacts

Public ContactDr Sourabh Dutta

Advanced Pediatric Centre PGIMER

drpkumarpgi@gmail.com

Outcome results

None listed

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