Noninvasive Hemodynamics Assessment of Preterms With Successful Medical Closure of PDA

Completed

• Conditions: Patent Ductus Arteriosus in Preterm Infants
• Interventions: Drug: I.V Paracetamol.; Device: Echocardiography.; Device: Electrical Cardiometry

• Registration Number: NCT06606015
• Lead Sponsor: Tanta University

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 \>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.

Study Timeline

• Study Start: 2023-10-01
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-18
• Study First Submitted QC: 2024-09-19
• Last Update Submitted: 2024-09-19
• Study First Posted: 2024-09-20
• Last Update Posted: 2024-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• All preterm newborns who were admitted throughout the duration of the research.

Exclusion Criteria

• Newborn with congenital heart diseases.
• Newborn with acquired heart diseases (viral myocarditis)
• Newborn with dysrhythmias
• Newborn with symptomatic cardiac dysfunction secondary to extra cardiac diseases
• Newborn with significant pulmonary hypertension or systemic hypertension

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Responders group:	I.V Paracetamol.	included 26 preterm infants who successfully responded to medical PDA closure
Responders group:	Echocardiography.	included 26 preterm infants who successfully responded to medical PDA closure
Non responders group:	Echocardiography.	included 17 preterm infants who didn't respond to medical PDA closure
Responders group:	Electrical Cardiometry	included 26 preterm infants who successfully responded to medical PDA closure
Non responders group:	I.V Paracetamol.	included 17 preterm infants who didn't respond to medical PDA closure
Non responders group:	Electrical Cardiometry	included 17 preterm infants who didn't respond to medical PDA closure

Primary Outcome Measures

Name	Time	Method
Stroke volume (SV)	6 months	Electrical cardiometry provides non-invasive hemodynamic monitoring. Electrical cardiometry provided a tool for continuous and non-invasive monitoring of Preterm Newborns with successful medical closure of PDA by evaluating: Stroke volume (SV): higher in non-responders.
Cardiac output (CO)	6 months	Electrical cardiometry provides non-invasive hemodynamic monitoring. Electrical cardiometry provided a tool for continuous and non-invasive monitoring of Preterm Newborns with successful medical closure of PDA by evaluating: Cardiac output (CO): higher in non-responders.
Systemic vascular resistance (SVR)	6 months	Electrical cardiometry provides non-invasive hemodynamic monitoring. Electrical cardiometry provided a tool for continuous and non-invasive monitoring of Preterm Newborns with successful medical closure of PDA by evaluating: Systemic vascular resistance (SVR): higher in responders.
Total fluid content (TFC)	6 months	Electrical cardiometry provides non-invasive hemodynamic monitoring. Electrical cardiometry provided a tool for continuous and non-invasive monitoring of Preterm Newborns with successful medical closure of PDA by evaluating: 3. Total fluid content (TFC): higher in non-responders.

Trial Locations

Locations (1)

Faculty of Medicine, Tanta University; 🇪🇬 Tanta, Egypt