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NCT Number: NCT06606015

Noninvasive Hemodynamics Assessment of Preterms With Successful Medical Closure of PDA

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

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Key information

Conditions

Patent Ductus Arteriosus in Preterm Infants

Age range

24 hour–7 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine, Tanta University

Tanta, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 cardiometry

Device

Non invasive hemodynamics monitoring

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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:

    • Total fluid content (TFC): higher in non-responders.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 20, 2024
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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