CLINICAL TRIAL ETAPA
ETAPA is a randomized, placebo-controlled trial of early targeted treatment of patent ductus arteriosus with paracetamol in extremely low birth weight infants. It is sponsored by University College Dublin and led by the principal investigator, Professor Jan Miletin.
In the Czech Republic, clinical trials are being conducted at two centres in Prague – the Motol Hospital and the Institute for Mother and Child Care in Podolí. Both centres were initiated during September 2023 and on 9 November 2023 the first subject was randomised in the centre Institute for Mother and Child Care, thus starting the clinical trial.
The planned recruitment of patients will take approximately one year.
Eudra-CT: 2020-004245-37
OVERVIEW OF RECRUITMENT
The recruitment of patients has started in October 2022.
Project documents
| ETAPA Multicentric ethics committee approval 19_04_2023 | Approval of KH SÚKL |
| Approval of KH SÚKL | Press release |