Prophylactic treatment of the ductus arteriosus in preterm infants by acetaminophen - TREOCAPA

INSERM The Institut national de la santé et de la recherche médicale0 个研究点目标入组 824 人开始时间: 2020年7月9日最近更新: 2020年9月15日

适应症

试验速览

暂无简介。

•Study population
•? The study population of the Phase II is constituted of 30 preterm infants of 23-26 weeks of gestational age (10 patients in 23-24 weeks of gestational age, 10 patients in 25 weeks of gestational age and 10 patients in 26 weeks of gestational age).
•? The study population of the Phase III, is constituted of 396 preterm infants of 23-26 weeks of gestational age and of 398 preterm infants of 27-28 weeks of gestational age
•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)
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•Non-inclusion criteria
•? Parental refusal
•? 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

发起方

INSERM The Institut national de la santé et de la recherche médicale