Noninvasive Hemodynamics Assessment of Preterms With Successful Medical Closure of PDA

NCT06606015 | Completed

• 1 other identifier: Hemodynamics with PDA closure
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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

Conditions

Patent Ductus Arteriosus in Preterm Infants

Keywords

PDA; Electrical Cardiometry; hemodynamics

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Responders group:

included 26 preterm infants who successfully responded to medical PDA closure

Drug: I.V Paracetamol.; Device: Echocardiography.; Device: Electrical Cardiometry

Non responders group:

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

Drug: I.V Paracetamol.; Device: Echocardiography.; Device: Electrical Cardiometry

Interventions

I.V Paracetamol. DRUG

Pharmacological thereby for hsPDA closure in the preterm neonates.

Non responders group:; Responders group:

Echocardiography. DEVICE

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

Non responders group:; Responders group:

Electrical Cardiometry DEVICE

Non invasive hemodynamics monitoring

Non responders group:; Responders group:

Eligibility Criteria

• Age: 24 Hours - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• All preterm newborns who were admitted throughout the duration of the research.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Medicine, Tanta University

Tanta, 31527, Egypt

Location

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Heba Elmahdy, Professor of Pediatrics

  Tanta University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pediatrics

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 20, 2024
• Study Start: October 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Locations

EG (1)