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Paracetamol vs Ibuprofen for PDA in Preterm Infants
NCT02056223Phase 3
Key facts
- Status
- Suspended
- Start
- Jan 2017
- Primary completion
- Oct 2019
- Countries
- 1
- Sponsor
- Università di Padova
- Modality
- Small Molecules
- Drugs
- acetaminophen
- Conditions
- patent ductus arteriosus (PDA)
01
Overview
Phase 3, randomised, double-blind trial of acetaminophen in patent ductus arteriosus (PDA) (2 arms), sponsored by Università di Padova. Primary endpoint: PDA pharmacological closure at 8 days. Started Jan 2017; status: suspended.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Paracetamol
Intravenous paracetamol 15 mg/Kg q6h for 3 days
Ibuprofen
Intravenous ibuprofen 10-5-5 mg/Kg daily for 3 days
03
Who it enrols
Preterm neonates (<= 31 weeks + 6 days gestation) with hemodynamically significant PDA and Respiratory Distress Syndrome. Excludes infants with severe IVH (> grade II), NEC, sepsis, severe coagulopathy, liver failure, or severe birth asphyxia.
04
Endpoints
Primary
PDA pharmacological closure
Secondary
Oliguria
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