| CTRI Number |
CTRI/2024/07/070994 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Abnormal findings on Echocardiographic studies in babies born prematurely and who requires support for breathing |
|
Scientific Title of Study
|
Echocardiographic abnormalities in very preterm babies requiring cardiorespiratory support- a prospective observational study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asha P T |
| Designation |
Senior Resident |
| Affiliation |
Kerala Institute Of Medical Sciences, Kerala |
| Address |
Department of Neonatology, 4th Floor, East Building, KIMSHEALTH, Anayara, Trivandrum
Thiruvananthapuram
KERALA
695029
India |
| Phone |
9604983439 |
| Fax |
|
| Email |
ptashanam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyothi Prabhakar |
| Designation |
Consultant |
| Affiliation |
Kerala Institute Of Medical Sciences, Kerala |
| Address |
Department of Neonatology,
KIMSHEALTH Hospital, Anayara , Trivandrum
Thiruvananthapuram
KERALA
695029
India |
| Phone |
9604983439 |
| Fax |
|
| Email |
jyothimeloor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Asha P T |
| Designation |
Senior Resident |
| Affiliation |
Kerala Institute Of Medical Sciences, Kerala |
| Address |
Department of Neonatology, 4th Floor, East Building, KIMSHEALTH, Anayara, Trivandrum
Thiruvananthapuram
KERALA
675011
India |
| Phone |
9604983439 |
| Fax |
|
| Email |
ptashanam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kerala Institute of Medical Sciences,Anayara, Thiruvananthapuram, Kerala , India, Pincode- 695029 |
|
|
Primary Sponsor
|
| Name |
Kerala Institute of Medical Sciences |
| Address |
Anayara, Trivandrum, 695029 |
| 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 |
| DR ASHA PT |
Kerala Institute Of Medical Sciences |
Department of Neonatology, 4th Floor, East Building, KIMSHEALTH, Pin code- 695029
Thiruvananthapuram
KERALA |
9604983439
ptashanam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHECKIMS HEALTH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: P229||Respiratory distress of newborn, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
7.00 Day(s) |
| Gender |
Both |
| Details |
1.Very Preterm babies requiring cardiorespiratory support
2.Very preterm babies requiring upgradation in respiratory support in the first week of life |
|
| ExclusionCriteria |
| Details |
Preterm babies not requiring cardiorespiratory support
Babies with lethal congenital anomalies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportions of echocardiographic studies with abnormalities |
3monnths, 6 months, 9months, 12months, 15 months, 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.
The proportion of babies abnormal echocardiographic findings having hemodynamic instability
2.
The proportion of babies having abnormal second echocardiography
3.
The short term outcomes in babies - period of NICU stay, survival |
3 months, 6 months, 9 months, 12months, 15 months, 18 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
03/08/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
All preterm babies (less than 32 weeks of gestation) requiring cardiorespiratory support will be included in the study. Functional echocardiography will be performed by a neonatologist trained in cardiac echocardiography within 24 hours starting of cardiorespiratory support in the first week of life. Results of the echo will be confirmed by a pediatric cardiologist.Parameters like left ventricular output, right ventricular output, mitral valve EA ratio, fractional shortening, inferior vena cava collapsibility index, PDA assessment, tricuspid regurgitation, TAPSE and septal motion will be documented in each echo examination. Echo findings will be compared with the hemodynamic status of each baby at that point of time. If any abnormal echo findings is documented that baby will be followed up by a repeat echo after 24 hrs. Any change in management plan done based on the echocardiographic findings if done will also be noted.
Unit. |