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Clinical Trials/NCT06606015
NCT06606015
Completed
N/A

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

Tanta University1 site in 1 country43 target enrollmentOctober 1, 2023

Overview

Phase
N/A
Intervention
I.V Paracetamol.
Conditions
Patent Ductus Arteriosus in Preterm Infants
Sponsor
Tanta University
Enrollment
43
Locations
1
Primary Endpoint
Stroke volume (SV)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2023
End Date
April 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lamiaa Khaled Zidan

Lecturer of Pediatrics

Tanta University

Eligibility Criteria

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

Arms & Interventions

Responders group:

included 26 preterm infants who successfully responded to medical PDA closure

Intervention: I.V Paracetamol.

Responders group:

included 26 preterm infants who successfully responded to medical PDA closure

Intervention: Echocardiography.

Responders group:

included 26 preterm infants who successfully responded to medical PDA closure

Intervention: Electrical Cardiometry

Non responders group:

included 17 preterm infants who didn't respond to medical PDA closure

Intervention: I.V Paracetamol.

Non responders group:

included 17 preterm infants who didn't respond to medical PDA closure

Intervention: Echocardiography.

Non responders group:

included 17 preterm infants who didn't respond to medical PDA closure

Intervention: Electrical Cardiometry

Outcomes

Primary Outcomes

Stroke volume (SV)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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.

Study Sites (1)

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