Noninvasive Hemodynamics Assessment of Preterms With Successful Medical Closure of PDA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hemodynamically Important Patent Ductus Arteriosus in Newborns Under 32 Weeks

NCT05686343

Patent Ductus Arteriosus After Premature Birth

UNKNOWN

Study of Thoracic Ultrasound As a Response to the Closure of Hemodynamically Significant Patent Ductus Arteriosus in Premature Infants

NCT06627374

Patency of the Ductus Arteriosus

RECRUITING

Pocket Echocardiography System (PES) for Detection of PDA in Neonates

NCT01790750

Patent Ductus Arteriosus

COMPLETED NA

The Efficacy of Implementing a Treatment Algorithm in Managing Patent Ductus Arteriosus (PDA) in the Extremely Low Birth Weight Neonatal Population.

NCT04379843

PDA Low; Birthweight, Extremely (999 Grams or Less)

COMPLETED

International Experience in Timing And Choices for Ductal Closure in Patent Ductus Arteriosus:INTERPDA Trial

NCT02910609

Patent Ductus Arteriosus

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patent Ductus Arteriosus in Preterm Infants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Responders group:

included 26 preterm infants who successfully responded to medical PDA closure

I.V Paracetamol.

Intervention Type DRUG

Pharmacological thereby for hsPDA closure in the preterm neonates.

Echocardiography.

Intervention Type DEVICE

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

Electrical Cardiometry

Intervention Type DEVICE

Non invasive hemodynamics monitoring

Non responders group:

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

I.V Paracetamol.

Intervention Type DRUG

Pharmacological thereby for hsPDA closure in the preterm neonates.

Echocardiography.

Intervention Type DEVICE

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

Electrical Cardiometry

Intervention Type DEVICE

Non invasive hemodynamics monitoring

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

I.V Paracetamol.

Pharmacological thereby for hsPDA closure in the preterm neonates.

Intervention Type DRUG

Echocardiography.

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

Intervention Type DEVICE

Electrical Cardiometry

Non invasive hemodynamics monitoring

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

24 Hours

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No