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

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

Study Overview

• Status: Completed
• Conditions: Patent Ductus Arteriosus in Preterm Infants
• Intervention / Treatment: Drug: I.V Paracetamol.; Device: Echocardiography.; Device: Electrical Cardiometry

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 Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 31527
    • Faculty of medicine, Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This study included 43 preterm neonates with hemodynamically significant PDA who received IV paracetamol as PDA medical closure. They were subdivided into 2 main groups responders and non responders to the PDA closure treatment.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Responders group: included 26 preterm infants who successfully responded to medical PDA closure	Drug: I.V Paracetamol.; Pharmacological thereby for hsPDA closure in the preterm neonates.; Device: Echocardiography.; It is routinely performed in neonates for PDA screening and detection of any other cardiac anomalies.; Device: Electrical Cardiometry; Non invasive hemodynamics monitoring
Non responders group: included 17 preterm infants who didn't respond to medical PDA closure	Drug: I.V Paracetamol.; Pharmacological thereby for hsPDA closure in the preterm neonates.; Device: Echocardiography.; It is routinely performed in neonates for PDA screening and detection of any other cardiac anomalies.; Device: Electrical Cardiometry; Non invasive hemodynamics monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	6 months

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Study Director: Heba Elmahdy, Professor of Pediatrics, Faculty of medicine, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 20, 2024

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: hemodynamics; PDA; Electrical Cardiometry
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Heart Defects, Congenital; Cardiovascular Abnormalities; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Ductus Arteriosus, Patent; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: Hemodynamics with PDA closure

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No