| CTRI Number |
CTRI/2024/03/063631 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study in newborn babies and children less than 5 years regarding low thyroid hormone problem noted since birth-number of new cases, cause and clinical data |
|
Scientific Title of Study
|
A study of incidence, clinical profile and etiology of congenital hypothyroidism in a tertiary care hospital. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka P |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College,MAHE,Manipal-576104 |
| Address |
Department of Paediatrics, Kasturba medical college, MAHE, Manipal, Udupi, Karnataka, 576104, India.
Udupi
KARNATAKA
576104
India |
| Phone |
7339293909 |
| Fax |
|
| Email |
priyankasandy94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Koushik H |
| Designation |
MD Paediatrics , Associate Professor, Department of Paediatrics |
| Affiliation |
Kasturba Medical College, MAHE , Manipal |
| Address |
Department of Paediatrics, Kasturba medical college, MAHE, Manipal, Udupi, Karnataka, 576104, India.
Udupi
KARNATAKA
576104
India |
| Phone |
9242308804 |
| Fax |
|
| Email |
koushik.h@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajendra Prasad |
| Designation |
DM Neonatology , Assistant Professor, Department of Neonatology |
| Affiliation |
Kasturba Medical College, MAHE , Manipal |
| Address |
Department of Neonatology, Kasturba medical college, MAHE, Manipal, Udupi, Karnataka, 576104, India.
Udupi
KARNATAKA
576104
India |
| Phone |
9592489919 |
| Fax |
|
| Email |
rajendra.anne@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College,Tiger circle road,Madhav nagar,Eshwar nagar, Manipal,Karnataka-576104 |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not applicable] |
|
|
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 Priyanka P |
Kasturba Medical College and Hospital -576104 |
Women and Children block, Department of Paediatrics and Department of Neonatology, Kasturba Medical College, Madhav Nagar, Manipal-576104, Udupi ,Karnataka
Udupi
KARNATAKA |
7339293909
priyankasandy94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E030||Congenital hypothyroidism with diffuse goiter, (2) ICD-10 Condition: E031||Congenital hypothyroidism withoutgoiter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
2 subgroups:
Subgroup 1: All term newborns admitted under Department of Neonatology undergoing NBS for Congenital Hypothyroidism
Subgroup 2: Children aged less than 5 years diagnosed with Congenital Hypothyroidism at an age ≤ 1 year at the Department of Paediatrics , Kasturba Medical College, Manipal |
|
| ExclusionCriteria |
| Details |
Children whose parents deny consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study incidence, clinical profile and etiology of congenital hypothyroidism in term newborns and clinical profile, etiology in children aged less than 5 years in whom congenital hypothyroidism is diagnosed at an age ≤ 1 year |
At admission (48 -72 hours of life) for term newborns in subgroup 1 and at follow up clinical visit in subgroup 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "5775"
Final Enrollment numbers achieved (India)="5775" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/03/2024 |
| Date of Study Completion (India) |
28/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
In subgroup 1 , all term newborns admitted under neonatology will be screened for congenital hypothyroidism after 48 - 72 hours of life (standard treatment) (TSH based screening) .Diagnosis of congenital hypothyroidism will be entertained as per ISPAE 2018 criteria. After diagnosis is confirmed : USG neck , Tc 99 thyroid scan, hearing test will be done as per standard of care. Clinical profile of such newborns will be documented . In subgroup 2 , children aged < 5 years who are already diagnosed to have congenital hypothyroidism coming up for follow up will be studied. Patients will be included in the study only if their thyroid function test at the time of diagnosis satisfy ISPAE 2018 diagnostic criteria . Detailed history, age ,investigations at the time of diagnosis , type of congenital hypothyroidism , dose of thyroxine , growth ,development and other relevant information will be documented. |