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Noninvasive Hemodynamics Assessment of Preterms With Successful Medical Closure of PDA

T

Tanta University

Status

Completed

Conditions

Patent Ductus Arteriosus in Preterm Infants

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT06606015
Hemodynamics with PDA closure

Details and patient eligibility

About

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

Full 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.

Enrollment

43 patients

Sex

All

Ages

24 hours to 7 days old

Volunteers

No Healthy Volunteers

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

Trial design

43 participants in 2 patient groups

Responders group:
Description:
included 26 preterm infants who successfully responded to medical PDA closure
Treatment:
Device: Echocardiography.
Device: Electrical Cardiometry
Drug: I.V Paracetamol.
Non responders group:
Description:
included 17 preterm infants who didn't respond to medical PDA closure
Treatment:
Device: Echocardiography.
Device: Electrical Cardiometry
Drug: I.V Paracetamol.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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