| CTRI Number |
CTRI/2021/10/037116 [Registered on: 05/10/2021] Trial Registered Prospectively |
| Last Modified On: |
01/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Incidence,Clinical status, and outcomes of children with increased pressure within lungs and its blood vessels |
|
Scientific Title of Study
|
Incidence,clinical profile,outcomes of pulmonary hypertension among children in Tertiary care hospital of coastal Karnataka |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meriyam Elizabeth koshy |
| Designation |
MSc CVT |
| Affiliation |
MCHP, MAHE ,MANIPAL |
| Address |
Room NO 202 2nd floor Department of CVT,MCHP,MAHE,Manipal
Room NO 202 2nd floor Department of CVT,MCHP,MAHE,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7026771810 |
| Fax |
|
| Email |
merikoshy6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akkatai S Teli |
| Designation |
Consultant Pediatric cardiologist |
| Affiliation |
Kasturba Medical College,Manipal |
| Address |
Department of cardiology
KMC, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8904819510 |
| Fax |
|
| Email |
drakssteli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akkatai S Teli |
| Designation |
Consultant Pediatric cardiologist |
| Affiliation |
Kasturba Medical College,Manipal |
| Address |
Department of cardiology
KMC, Manipal
KARNATAKA
576104
India |
| Phone |
8904819510 |
| Fax |
|
| Email |
drakssteli@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Cardiology,Kasturba Medical College and Hospital,Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College and Hospital |
| Address |
Department of Cardiology, Kasturba Hospital ,Manipal Academy of Higher Education,Manipal |
| 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 |
| Meriyam Elizabeth Koshy |
Kasturba hospital |
Department of Cardiology ,Room no34,echo room,2nd floor KMC hospital
Udupi
KARNATAKA |
7026771810
merikoshy6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Kasturba Medical College and Hospital ,Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I27||Other pulmonary heart diseases, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Pulmonary Hypertension associated with Congenital Heart Disease
Infants with Pulmonary Hypertension without underlying Congenital Heart Disease (including Primary pulmonary Hypertension)
Idiopathic Pulmonary Artery Hypertension |
|
| ExclusionCriteria |
| Details |
Neonatal Pulmonary Artery Hypertension in a stable baby
Mild residual Pulmonary Artery Hypertension after corrective surgery
Pulmonary Artery Hypertension crisis (an emergency situation after intervention) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overall clinical outcome of pulmonary hypertension among children |
BASELINE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation between echocardiographic parameters and disease severity, clinical outcomes in children with pulmonary hypertension |
BASELINE |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
07/10/2021 |
| 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
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is conducted to study the clinical profile , incidence ,etiology and outcomes of children with pulmonary hypertension and also to use and compare various echocardiographic parameters to diagnose pediatric PH, to assess clinical severity and outcomes after treatment
|