| CTRI Number |
CTRI/2026/01/101208 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Early Diagnosis for Better Health: Screening Newborns for Cystic Fibrosis in South India |
|
Scientific Title of Study
|
A systematic pilot feasibility project to develop newborn screening for cystic fibrosis (CF NBS) in a community in South India |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sneha Deena Varkki |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of pediatrics unit 3
Christian Medical College
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
04162283344 |
| Fax |
|
| Email |
snehatitus85@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sneha Deena Varkki |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of pediatrics unit 3
Christian Medical College
Vellore
TAMIL NADU
632004
India |
| Phone |
04162283344 |
| Fax |
|
| Email |
snehatitus85@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sneha Deena Varkki |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of pediatrics unit 3
Christian Medical College
Vellore
TAMIL NADU
632004
India |
| Phone |
04162283344 |
| Fax |
|
| Email |
snehatitus85@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Cystic Fibrosis Foundation |
|
|
Primary Sponsor
|
| Name |
Cystic Fibrosis Foundation |
| Address |
4550 Montgomery Avenue, Suite 1100N, Bethesda, MD 20814, USA |
| Type of Sponsor |
Other [Non Profit Organisation] |
|
|
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 Sharanya R |
Government Vellore Medical College (GVMC) |
Arni Road, Adukkamparai, Vellore, Tamil Nadu 632011
Vellore
TAMIL NADU |
9842349639
dr.sharanya.r@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD OFFICE OF RESEARCH CHRISTIAN MEDICAL COLLEGE VELLORE INDIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Newborn babies |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
3.00 Day(s) |
| Gender |
Both |
| Details |
All live-born infants more than 28 weeks gestational age and more than 1000 grams will be eligible. Infants with meconium ileus will also undergo sweat testing and DNA analysis irrespective of IRT levels.
Preterm babies (more than 28 weeks and more than 1000gm) who need admission to neonatal ICU will be recruited after initial stabilisation and treatment of respiratory distress. |
|
| ExclusionCriteria |
| Details |
Stillborn infants, and critically ill infants due to potential high IRT-1 levels secondary to perinatal stress, difficulties with IRT-2 sampling, and other medical co-morbidities. Families who are travelling out of Vellore and surrounding districts and cannot come back for retesting (if the need arises) will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
a. Feasibility of IRT/IRT/ and limited DNA algorithm (measured as % recruitment, % retention, % valid sample rate)
b. Diagnostic yield (number of confirmed CF cases per 1000 infants screened)
c. Correlation between heel prick IRT and cord blood IRT
d. Number of false positives / false negatives
e. Turn-around time from sample to diagnosis
f. Seasonal variation in IRT levels
g. Response rate to follow-up weight monitoring (via phone/NBS card) |
First 3 months capacity building, 1 to 6 months Personnel recruitment and training, 2 to 24 months participant enrollment and follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- Diagnostic yield (number of confirmed CF cases per 1000 infants screened)
- Correlation between heel prick IRT and cord blood IRT
- Number of false positives / false negatives
- Turn-around time from sample to diagnosis
- Seasonal variation in IRT levels
- Response rate to follow-up weight monitoring (via phone/NBS card) |
First 3 months capacity building, 1 to 6 months Personnel recruitment and training, 2 to 24 months participant enrollment and follow up |
|
|
Target Sample Size
|
Total Sample Size="20000"
Sample Size from India="20000"
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)
|
01/04/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cystic fibrosis (CF) is a serious inherited condition that affects the lungs and digestive system, often leading to early death if not diagnosed and treated early. Many children in India are diagnosed too late, after developing complications. This study will check feasibility of using a test which is used world over to screen newborns. The test screens babies for possibility of CF using a small drop of blood collected from the baby’s heel and from the umbilical cord (cord blood). Our goal is to find out if such a newborn screening program is possible in this region and if it could later be used more widely. We will recruit babies born in two hospitals in Vellore. Parents will be asked for consent. Babies with abnormal results will be invited for further testing to confirm if they have CF. All information will be kept confidential, and families will receive support and counselling throughout the process. The proposal has been approved for funding by Cystic Fibrosis Foundation. |