| CTRI Number |
CTRI/2020/04/024933 [Registered on: 30/04/2020] Trial Registered Prospectively |
| Last Modified On: |
28/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To know the various types of hemoglobins present in the newborns. |
|
Scientific Title of Study
|
Identification Of Hemoglobin Variants By Newborn Screening |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sakshi Agarwal |
| Designation |
Post Graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics,
Maulana Azad Medical College & Associated LN Hospital, New Delhi
Central
DELHI
110002
India |
| Phone |
7838992360 |
| Fax |
|
| Email |
agarwal.sakshi1332@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Kapoor |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics
Maulana Azad Medical College & Associated LN Hospital, New Delhi
Central
DELHI
110002
India |
| Phone |
9868846606 |
| Fax |
|
| Email |
drseemakapoor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Kapoor |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics
Maulana Azad Medical College & Associated LN Hospital, New Delhi
Central
DELHI
110002
India |
| Phone |
9868846606 |
| Fax |
|
| Email |
drseemakapoor@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Paediatrics |
| Address |
Maulana Azad Medical College |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Sakshi Agarwal |
Maulana Azad Medical College & Associated LN Hospital |
Department of Pediatrics
Central
DELHI |
7838992360
agarwal.sakshi1332@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
hemoglobinopathy |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Healthy term neonates born at Lok Nayak Hospital on odd dates as per calender date. |
|
| ExclusionCriteria |
| Details |
1. Newborns with history of previous blood transfusions
2. Newborns found to have HbA fractions of less than or equal to 15%(reflecting quantitative change in beta globin chain)
3. Newborns born on even days as per calender date of birth |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of different hemoglobin variants in the study population. |
at birth, 6 weeks and 14 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Proportion of neonates having co-inherited variants
2.Proportion of parents and siblings carrying same variant |
at birth,6 weeks and 14 weeks |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hemoglobinopathies are considered important newborn screening targets. They are a result of structural abnormalities in the hemoglobin molecule. Most studies in India and south east Asian countries have been done in antenatal periods or high risk groups. Identification of hemoglobin variants in the neonatal period helps us to do nearly interventions, education of family in terms of genetic and reproductive counseling and long term support of persistent anemias. There has been scarcity of published data on prevalence of various hemoglobin variants in northern India and their clinical implications. We attempt to study the proportion of structurally abnormal variants in neonatal population presenting to a tertiary care institution of North India. |