| CTRI Number |
CTRI/2021/04/032521 [Registered on: 05/04/2021] Trial Registered Prospectively |
| Last Modified On: |
22/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Metabolic Tests in Infants presenting with Developmental Delay |
|
Scientific Title of Study
|
Role of Metabolic Evaluation in Infants presenting with Global Developmental Delay |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 859 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rochelle Natasha Gomes |
| Designation |
Junior Resident, Department of Paediatrics |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Department of Paediatrics, Kasturba Medical College and Hospital
MAHE
MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
9743224111 |
| Fax |
|
| Email |
natashargomes@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Bhat Y |
| Designation |
Professor and Unit Head |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Department of Paediatrics,
Kasturba Medical College and Hospital
MAHE
MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
9686401313 |
| Fax |
|
| Email |
docrameshbhat@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandesh Kini B |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Department of Paediatrics,
Kasturba Medical College and Hospital
MAHE
MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
9731149519 |
| Fax |
|
| Email |
sandesh.kini@manipal.edu |
|
|
Source of Monetary or Material Support
|
| KMC Hospital, MAHE, Manipal, Udupi, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Rochelle Natasha Gomes |
| Address |
Junior Resident, Department of Paediatrics,
Kasturba Medical College and Hospital,
MAHE,
Manipal-576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| not applicable |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rochelle Natasha Gomes |
Kasturba Medical College and Hospital |
Department of Paediatrics,
KMC Manipal, MAHE, Manipal- 576104
Udupi
KARNATAKA |
9743224111
natashargomes@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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: F88||Other disorders of psychological development, (2) ICD-10 Condition: E889||Metabolic disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 1 month to 1 year admitted in the Department of Paediatrics and presenting with GDD (global developmental delay with unclear etiology, progressive encephalopathy with seizures, hypotonia with or without poor feeding, failure to thrive, respiratory distress or vomiting).
2. Children with hypoglycaemic encephalopathy.
|
|
| ExclusionCriteria |
| Details |
1. Children lesser than 1 month of age or older than 1 year at presentation.
2. Children with identified causes of GDD such as perinatal asphyxia/ hypoxic ischaemic encephalopathy stage 2 or 3, TORCH infections, post-meningitis sequelae, chromosomal disorder, hypothyroidism etc.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To establish the role of initial metabolic workup, Tandem Mass Spectrometry (TMS) and Gas Chromatography- Mass Spectrometry (GC-MS) in infants presenting with global developmental delay.
|
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To obtain the clinical profile of infants presenting with GDD requiring metabolic workup.
|
2 years |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="53" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/04/2021 |
| Date of Study Completion (India) |
30/09/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a prospective, clinical: single centre, observational study to determine the role of metabolic workup in children aged 3 months to 2 years with Global Developmental Delay (GDD) and to study the clinical profile of children aged 3 months to 2 years presenting with GDD requiring metabolic workup. This study will be conducted in a single centre in India- Department of Paediatrics, Kasturba Medical College and Hospital, MAHE, Manipal, Karnataka, India. The primary outcome is to establish the role of metabolic workup in children aged 3 months to 2 years presenting with GDD. The secondary outcome is to obtain the clinical profile of children aged 3 months to 2 years presenting with GDD requiring metabolic workup. |