A Randomised Controlled Trial of Early Targeted Patent Ductus Arteriosus Treatment Using a Risk Based Severity Score

Phase 1

• Conditions: Patent Ductus Arteriosus; MedDRA version: 18.1Level: PTClassification code 10034130Term: Patent ductus arteriosusSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-004526-33-IE
• Lead Sponsor: Royal College of Surgeons in Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-03
• Last Update Posted: 15 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

All infants less than 29 weeks admitted to the NICU with a PDA identified on echocardiography between 36 and 48 hours of life will be eligible for inclusion. A comprehensive assessment of PDA significance will be performed using echocardiography to derive a PDA risk score based on this following formula: Infants with a risk score = 5.0 are deemed to be at high risk of developing CLD/Death and will be randomised to either arm

(Gestation in weeks × -1.304) + (PDA diameter in mm × 0.781) + (Left ventricular output in ml/kg/min × 0.008) + (maximum PDA velocity in m/s × -1.065) + (LV a` wave in cm/s × -0.470) + 41, where 41 is the constant of the formula.

Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The following infants will be excluded:

•lack of consent or study investigators
•lethal congenital abnormality or obvious syndrome
•pulmonary hypoplasia
•active bleeding
•known or suspected NEC
•platelet count < 100/mm2
•creatinine > 100 µmol/L; neutropenia
•oliguria < 1ml/kg/hour
•congenital heart disease other than a PDA or a patent foramen ovale
•grade 3 or higher IVH

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified