Randomised Placebo-Controlled Trial of Early Targeted Treatment of Patent Ductus Arteriosus with Paracetamol in Extremely Low Birth Weight Infants (ETAPA) - ETAPA

niversity College Dublin0 sites218 target enrollmentOctober 30, 2020

Overview

No summary available.

Registry

who.int

Start Date

October 30, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity College Dublin

•\-They are inborn or transferred to a participating centre after birth and have a birth weight of \<1000g established by weight assessment on admission to NICU.
•\-The treating doctors plan to offer them intensive care.
•\-Large PDA is present on fnECHO, defined as PDA with diameter greater than 1\.5mm with non\-restrictive flow (defined as diastolic flow less than 50% of systolic flow)(25\), determined by targeted fnECHO between 6 and 12 hours of age.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 218
•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

•\-Infants with major congenital anomalies including neural tube defects, major structural cardiac anomalies (excluding PDA/ASD/PFO), abdominal wall defects and congenital diaphragmatic hernia and major dysmorphic features with an abnormal karyotype e.g. T21, T13, T18\.
•\-The treating clinician does not intend to offer the infant intensive care.
•\-Bidirectional shunt of PDA on ECHO (defined as shunt exceeding 30% of the right to left proportion of the shunting).
•\-Grade II – IV IVH on point of care CRUSS on screening (between six to twelve hours of age).
•\-PH prior to study commencement.
•\-Severe PPHN.
•\-History or examination suggestive of liver failure prior to study commencement.
•\-Written informed consent has not been obtained before the infant is 12 hours of age, or the infant’s parent(s)/guardian(s) withdraw consent prior to commencement of the trial processes or assessments.