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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06606015
Enrollment
43
Registered
2024-09-20
Start date
2023-10-01
Completion date
2024-04-01
Last updated
2024-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patent Ductus Arteriosus in Preterm Infants

Keywords

PDA, Electrical Cardiometry, hemodynamics

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.

Interventions

DRUGI.V Paracetamol.

Pharmacological thereby for hsPDA closure in the preterm neonates.

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

Non invasive hemodynamics monitoring

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
24 Hours to 7 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Stroke volume (SV)6 monthsElectrical 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 monthsElectrical 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 monthsElectrical 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 monthsElectrical 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026