Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen
Status:
Recruiting
Trial end date:
2023-07-01
Target enrollment:
Participant gender:
Summary
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