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

Completed

• Conditions: neonates requiring PRBC transfusion

• Registration Number: CTRI/2014/10/005094
• Lead Sponsor: PGIMER

Brief Summary

This study observational study to see the rise of hematocrit after packed red blood cells transfusion. In this study all eligible neonatess will identified and enrolled as per criteria. primary otcome will be baseline hematocrit will done and after PRBC transfusion completion at 15 min. secondary otcome to see rise of hematocrit  6 hours and 24 hours and to compare at 15 min and 6 hours. various factor affecting rise of hematocrit ( neonatal factors as well as blood donor factor)will noted. to see the evidence of hemolysis total serum bilirubin,  peripheral blood smear and plasma hemoglobin will done at baseline and 24 hours of transfusion.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-07
• Last Update Posted: 2014-09-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 110

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 Coomb’s test, exaggerated reticulocyte response or peripheral smear showing evidence of hemolysis) •Previous ‘out of study’ 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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Percent rise in hematocrit at 15 minutes after PRBC transfusion.	15 min

Secondary Outcome Measures

Name	Time	Method
•Percent rise in hematocrit at 6 hours after PRBC transfusion.	•Factor affecting the rise of hematocrit

Trial Locations

Locations (1)

Newborn unit, PGIMER, Chandigarh; 🇮🇳 Chandigarh, CHANDIGARH, India

Newborn unit, PGIMER, Chandigarh

🇮🇳Chandigarh, CHANDIGARH, India

Rakesh Kumar Pilania

Principal investigator

8872114008

kumarpilania007@gmail.com