A randomised controlled trial of early targeted patent ductus arteriosus treatment using a risk-based severity score

Royal College of Surgeons in Ireland0 sites60 target enrollmentJuly 26, 2016

Overview

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33069668/ results (added 20/10/2020) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/33310351/ cohort study (added 16/12/2020) 2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34522836/ RCT protocol (added 21/09/2021) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35585179/ (added 18/08/2023)

Registry

who.int

Start Date

July 26, 2016

End Date

August 1, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•All infants aged 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 using a mathematical formula:
•(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
•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.

•1\. Lack of consent or study investigators to carry out echocardiogram examination
•2\. Lethal congenital abnormality or obvious syndrome
•3\. Pulmonary hypoplasia
•4\. Known or suspected NEC
•5\. Thrombocytopenia: platelet count \< 100/mm2
•6\. Impaired renal function creatinine \> 100 µmol/L; and/or oliguria \< 1ml/kg/hour
•7\. Culture positive sepsis
•8\. Congenital heart disease other than a PDA or a patent foramen ovale
•9\. Active bleeding including grade 3 or higher IVH or gastrointestinal haemorrhage