Clinical trial NCT06606015: Noninvasive Hemodynamics Assessment of Preterms With Successful Medical Closure of PDA
Official title: Noninvasive Hemodynamics Assessment of Preterm Newborns With Successful Medical Closure of Patent Ductus Arteriosus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patent Ductus Arteriosus in Preterm Infants
Keywords: PDA
Electrical Cardiometry
hemodynamics
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-09-20
Enrollment: 43
Sex: ALL
Minimum age (years): 24
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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 \&gt;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.

Eligibility criteria: 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

Primary outcomes:
measure: Stroke volume (SV)
timeFrame: 6 months
measure: Cardiac output (CO)
timeFrame: 6 months
measure: Systemic vascular resistance (SVR)
timeFrame: 6 months
measure: Total fluid content (TFC)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine, Tanta University
Study officials:
affiliation: Tanta University
name: Heba Elmahdy, Professor of Pediatrics
role: STUDY_DIRECTOR
References: