WHO ICTRP trial

Prophylactic treatment of the ductus arteriosus in preterm infants by…

EUCTR2019-004297-26-FR · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2019-004297-26-FR
Public title Prophylactic treatment of the ductus arteriosus in preterm infants by paracetamol
Scientific title Prophylactic treatment of the ductus arteriosus in preterm infants by acetaminophen - TREOCAPA
Primary sponsor Institut National de la Santé et de la Recherche Médicale (INSERM)
Registry EU Clinical Trials Register
Recruitment status Authorised
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries Belgium;Portugal;Estonia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Hungary;Poland;Denmark;Norway;Sweden
Conditions Patent ductus arteriosus;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Interventions Trade Name: Paracetamol Pharmaceutical Form: Solution for infusion INN or Proposed INN: acetaminophen Other descriptive name: PARACETAMOL Concentration unit: mg/kg milligram(s)/kilogram Concentration type: up to Concentration number: 0.75…
Registration date Feb 28, 2020
Target size 824
Secondary IDs C19-29
Registry page clinicaltrialsregister.eu

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