Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533787
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Impact of Echocardiography on Management of Critically Ill Neonates
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Echocardiography on Management of Critically Ill Neonates
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of the study was to estimate the outcome mortality and morbidity among hemodynamically unstable neonates as well as the time to return to hemodynamic stability following the use of ECHO in the management of hemodynamically unstable neonates
Detailed Description:
-All patients will be subjected to Full clinical examination for manifestation or signs of hemodynamic instability and daily thereafter until discharge
An echocardiographic assessment using Vivid T8 Pro GE MEDICAL SYSTEMS CHINA CO LTD is done if manifestations of hemodynamic instability or shock appeared
The imaging planes were identified by transducer location subxiphoid apical parasternal suprasternal notch and right parasternal The segmental approach was used to describe all of the major cardiovascular structures in sequence
Suggested plan of management will be as the following
1 Neonates with low LVO and impaired left ventricular contractility dobutamine at a dose of 5-20 μgkgmin was given and if no improvement volume expansion as a single intravenous infusion of 10-20 mlkg of the crystalloid solution was given If still no improvement hydrocortisone at a dose of 1 mgkg every 4 h was added If improvement was not achieved epinephrine was added at a dose of 005-26 μgkgmin 11
2 Neonates with LVO and hypovolemia under-filled left ventricle volume expansion as a single intravenous infusion of 10-20 mlkg of the crystalloid solution will be given If still no improvement it was repeated 11
3 Neonates with normal or high LVO without PDA dopamine at a dose of 5-20 μgkgmin is given If no improvement hydrocortisone at a dose of 1 mgkg every 4 h is added If improvement was not achieved epinephrine is added at a dose of 005-26 μgkgmin 11
4 Neonates with normal or high LVO and hemodynamically significant PDA PDA will be treated either medically or surgically 11
5 During the current study period all previously mentioned hemodynamically unstable neonate values were compared to values collected from the controlled group 200 hemodynamically stable neonates
6 Neonates will be monitored regularly and subjected to repeated echocardiographic and clinical examinations to detect clinical and laboratory findings suggestive of hemodynamic instability or shock
An echocardiographic assessment using Vivid T8 Pro GE MEDICAL SYSTEMS CHINA CO LTD is done if manifestations of hemodynamic instability or shock appeared
The imaging planes were identified by transducer location subxiphoid apical parasternal suprasternal notch and right parasternal The segmental approach was used to describe all of the major cardiovascular structures in sequence
Suggested plan of management will be as the following
1 Neonates with low LVO and impaired left ventricular contractility dobutamine at a dose of 5-20 μgkgmin was given and if no improvement volume expansion as a single intravenous infusion of 10-20 mlkg of the crystalloid solution was given If still no improvement hydrocortisone at a dose of 1 mgkg every 4 h was added If improvement was not achieved epinephrine was added at a dose of 005-26 μgkgmin 11
2 Neonates with LVO and hypovolemia under-filled left ventricle volume expansion as a single intravenous infusion of 10-20 mlkg of the crystalloid solution will be given If still no improvement it was repeated 11
3 Neonates with normal or high LVO without PDA dopamine at a dose of 5-20 μgkgmin is given If no improvement hydrocortisone at a dose of 1 mgkg every 4 h is added If improvement was not achieved epinephrine is added at a dose of 005-26 μgkgmin 11
4 Neonates with normal or high LVO and hemodynamically significant PDA PDA will be treated either medically or surgically 11
5 During the current study period all previously mentioned hemodynamically unstable neonate values were compared to values collected from the controlled group 200 hemodynamically stable neonates
6 Neonates will be monitored regularly and subjected to repeated echocardiographic and clinical examinations to detect clinical and laboratory findings suggestive of hemodynamic instability or shock
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None