Prophylactic treatment of the ductus arteriosus in preterm infants by paracetamol

Phase 1

• Conditions: Patent ductus arteriosus; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]; MedDRA version: 20.0Level: LLTClassification code 10034129Term: Patent ductus arteriosisSystem Organ Class: 100000004850

• Registration Number: EUCTR2019-004297-26-IT
• Lead Sponsor: INSERM-ANRS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-21
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 794

Inclusion Criteria

- Birth between 23-28 W
- Post natal age < 12 hours
- Parental or Legal Authority Consent
- Parents with a social security or health insurance (if applicable)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

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