| CTRI Number |
CTRI/2014/10/005094 [Registered on: 13/10/2014] Trial Registered Retrospectively |
| Last Modified On: |
26/09/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
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 of Study
|
Determinants of Efficacy of Packed Red Blood Cells Transfusion in Neonates |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakesh Kumar Pilania |
| Designation |
Junior Resident |
| Affiliation |
Advanced Pediatric Centre PGIMER |
| Address |
Department of Pediatrics Advanced Pediatric Centre PGIMER
Chandigarh
CHANDIGARH
160012
India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8872114008 |
| Fax |
|
| Email |
kumarpilania007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen kumar |
| Designation |
Professor |
| Affiliation |
Advanced Pediatric Centre PGIMER |
| Address |
Newborn Unit
Department of Pediatrics
PGIMER
Sector 12
Chandigarh 160012
India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
drpkumarpgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sourabh Dutta |
| Designation |
Additional Professor |
| Affiliation |
Advanced Pediatric Centre PGIMER |
| Address |
Newborn Unit
Department of Pediatrics
PGIMER
Sector 12
Chandigarh 160012
India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
sourabhdutta@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| post graduate institute of medical education and research,chandigarh |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
PGIMER,sector 12, chandigarh 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rakesh Kumar Pilania |
Newborn unit, PGIMER, Chandigarh |
Department of
Pediatrics, Post
Graduate Institute of
Medical Education and
Research, Chandigarh
Chandigarh
CHANDIGARH
Chandigarh
CHANDIGARH |
8872114008
kumarpilania007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
neonates requiring PRBC transfusion, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
• 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.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •Percent rise in hematocrit at 15 minutes after PRBC transfusion. |
15 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Percent rise in hematocrit at 6 hours after PRBC transfusion.
• Factor affecting the rise of hematocrit
• Percent rise in hematocrit at15 min, 6 hours and 24 hours of G6PD deficient PRBC transfusion
• 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.
|
6 hour and 24 hours |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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.
|