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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/10/005094
• Date of registration: 13-10-2014
• Prospective Registration: No
• Primary sponsor: PGIMER
• Public title: To find out the rise in hemoglobin and to study the effect of various factors on rise in hemoglobin after blood transfusion in newborn
• Scientific title: Determinants of Efficacy of Packed Red Blood Cells Transfusion in Neonates
• Date of first enrolment: 01-07-2012
• Target sample size: 110
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=8120
• Study type: Observational
• Study design: Other; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Dr Sourabh Dutta
• Affiliation: Advanced Pediatric Centre PGIMER

• Name: Dr Praveen kumar
• Affiliation: Advanced Pediatric Centre PGIMER

Key inclusion & exclusion 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: • 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.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- neonates requiring PRBC transfusion

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

NIL

Source(s) of Monetary Support

post graduate institute of medical education and research,chandigarh

Ethics review

Status: Approved
Approval date: 31/12/2012
Contact:

Ethics committee PGIMER