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 enrollmentJanuary 10, 2023

Overview

No summary available.

Registry

who.int

Start Date

January 10, 2023

End Date

TBD

Last Updated

last year

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), 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.