Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Collaborators: Connect for Children; European Fundation for the Care of the Newborn Infants; PARTNERS for International clinical Research; UPCET
• Treatments: Acetaminophen

Criteria

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

• 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