Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606015
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Noninvasive Hemodynamics Assessment of Preterms With Successful Medical Closure of PDA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Noninvasive Hemodynamics Assessment of Preterm Newborns With Successful Medical Closure of Patent Ductus Arteriosus
Status:
COMPLETED
Status Verified Date:
2024-09
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 aim of our study was to use Electrical Cardiometry EC to monitor hemodynamic alternations during pharmacological closure of hemodynamically significant patent ductus arteriosus hsPDA in preterm neonates
Detailed Description:
PDA in the first three days of life is a normal physiologic remnant in healthy term neonates Conversely a PDA in preterm neonates causes significant clinical sequelae as a result from left to right shunting It is widely recognized that a hemodynamically significant PDA is known to contribute to increased morbidity and mortality The increase in pulmonary blood flow in the setting of prematurity leads to pulmonary edema noncompliant lungs and worsening of respiratory status Other sequelae of a hemodynamically significant PDA include intraventricular hemorrhage necrotizing enterocolitis congestive heart failure and failure to thrive
Echocardiography is often used to evaluate hemodynamic significance of PDA In general pharmacological closure of PDA is less successful in infants with ductal diameter gt2mm Lower ductal maximum velocity which is usually associated with a larger PDA or higher pulmonary pressure is another predictor of treatment failure
The use of echocardiography to gather meaningful hemodynamic data often necessitates serial assessments that can be tedious and labor-intensive Electrical cardiometry EC is a non-invasive impedance-based monitor that provides absolute cardiac output estimates in clinical practice Unlike echocardiography EC is simple to apply continuous in measurements and not operator dependent
Echocardiography is often used to evaluate hemodynamic significance of PDA In general pharmacological closure of PDA is less successful in infants with ductal diameter gt2mm Lower ductal maximum velocity which is usually associated with a larger PDA or higher pulmonary pressure is another predictor of treatment failure
The use of echocardiography to gather meaningful hemodynamic data often necessitates serial assessments that can be tedious and labor-intensive Electrical cardiometry EC is a non-invasive impedance-based monitor that provides absolute cardiac output estimates in clinical practice Unlike echocardiography EC is simple to apply continuous in measurements and not operator dependent
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