NCT06606015 - Noninvasive Hemodynamics Assessment of Preterms With Successful Medical Closure of PDA | Crick

Overview

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

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 Type

OBSERVATIONAL

Enrollment

43

Conditions

Patent Ductus Arteriosus in Preterm Infants

Interventions

I.V Paracetamol.DRUG

Pharmacological thereby for hsPDA closure in the preterm neonates.

Echocardiography.DEVICE

It is routinely performed in neonates for PDA screening and detection of any other cardiac anomalies.

Electrical CardiometryDEVICE

Non invasive hemodynamics monitoring

Eligibility

Sex: ALLMin age: 24 HoursMax age: 7 Days

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Medicine, Tanta University

Tanta, Egypt

Outcomes

Primary Outcomes

Stroke volume (SV)

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.

Time frame: 6 months

Cardiac output (CO)

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.

Time frame: 6 months

Systemic vascular resistance (SVR)

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.

Time frame: 6 months

Total fluid content (TFC)

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.

Time frame: 6 months