Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen

C19-29

TREOCAPA is a Phase II/III European Multicentre study concerning the prophylactic treatment by Acetaminophen of extremely preterm infant during the first five days after birth. The Phase II is a dose finding phase in order to assess the minimum effective dose regimen of acetaminophen for the closure of PDA for neonates with a gestational age less than 27 weeks This part of the study will be conducted in 11 NICUs, in 4 countries (France, UK, Finland and Denmark). The Phase III is The phase III is a randomized, multicenter, double-blind, placebo-controlled superiority trial, two arms in a 1:1 ratio, evaluating an increasing of 10% of the percentage of survival without severe morbidity at 36 weeks of post menstrual age. In the intervention arm, 20 mg/kg followed by 7.5 mg/kg quarter in die (QID) will be administered to the 27-28 weeks gestational age group (dosage confirmed through PK/PD data analysis from the previous Finnian study) and the dosage selected after the conclusion of the Phase II will be administered to the 23-26 weeks gestational age group. A group sequential design, with a total of 3 analyses (2 interim analyses and a final) and the O'Brien-Fleming alpha spending function is chosen for the trial. At the same time, a Bayesian sequential analysis is planned for safety endpoints

2020-10-29

2024-07-01

2024-07-01

Active (not recruiting)

Early phase I

824

Inclusion Criteria: * Birth between 23-26 W for Phase II, between 23-28 W for Phase III * Post natal age \< 12 hours * Parental or Legal Authority Consent * Parents with a social security or health insurance (if applicable according to the local regulation) Exclusion Criteria: * Birth defect / Congenital anomaly * Twin-to-twin transfusion syndrome not cured * Suspicion of pulmonary hypoplasia * Suspicion of hepatic impairment (hemorrhagic syndrome and/or severe hypoglycemia) * Clinical instability that can lead to rapid death * Impossibility to start treatment before 12 hours of life * Parents placed under judicial protection * Participation in other clinical trial using acetaminophen during the first 5 days of life, indomethacin or ibuprofen during the first 3 days of life or using rescue treatment of PDA not recommended in the TREOCAPA trial

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2024-04-11