Paracetamol and Patent Ductus Arteriosus closure: Pharmacokinetic-Pharmacodynamic study

Not Applicable

Recruiting

• Conditions: Patent Ductus Arteriosus (PDA) in preterm neonates; Paracetamol therapy for PDA closure.; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12623001197628
• Lead Sponsor: Monash Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-20
• Last Update Posted: 4 December 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Preterm neonate (<28 weeks GA) with haemodynamically significant PDA (hsPDA) determined by echocardiography.
An echocardiography will be performed using Vivid E95 equipment (GE Vingmed Ultrasound, Horten, Norway). A PDA scoring schema will be calculated using the parameters: PDA size and velocity, PDA:left pulmonary artery ratio, diastolic flow in main and left pulmonary artery, left atria:aortic (LA:Ao) ratio and left ventricular:aortic ratio. Each parameter scores a maximum 3 points, the maximum score being 21

Exclusion Criteria

Preterm neonates (<28wks) without haemodynamically significant PDA

Study & Design

• Study Type: Observational
• Study Design: Not specified