NCT06606015

Noninvasive Hemodynamics Assessment of Preterms With Successful Medical Closure of PDA

Noninvasive Hemodynamics Assessment of Preterm Newborns With Successful Medical Closure of Patent Ductus Arteriosus

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 43 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 24 Hours – 7 Days
• Healthy volunteers: Not accepted

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 \>2mm. 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.

Conditions

• Patent Ductus Arteriosus in Preterm Infants

Interventions

Type	Name	Description
DRUG	I.V Paracetamol.	Pharmacological thereby for hsPDA closure in the preterm neonates.
DEVICE	Echocardiography.	It is routinely performed in neonates for PDA screening and detection of any other cardiac anomalies.
DEVICE	Electrical Cardiometry	Non invasive hemodynamics monitoring

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2024-09-20
• Last updated: 2024-09-20

Locations

1 site across 1 country: Egypt