Treocapa: Prophylactic treatment of the ductus arteriosus in preterm infants by acetaminophe

Phase 1

• Conditions: Prophylactic treatment of the ductus arteriosus in preterm infants; MedDRA version: 20.0Level: PTClassification code 10034130Term: Patent ductus arteriosusSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2019-004297-26-GB
• Lead Sponsor: INSERM The Institut national de la santé et de la recherche médicale

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-09
• Last Update Posted: 15 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 824

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified