At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 19 enrolled
Drug / intervention
Paracetamol +2 moredrug
Likely dose
Paracetamol 15 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Paracetamol (Acetaminophen) for Closure of PDA in Preterm Infants
In Brief
A Phase 3 clinical trial evaluating Paracetamol, Ibuprofen, and 1 other intervention for PDA. Completed, enrolled 19 participants across 1 site.
Detailed Summary
There is a report that acetaminophen may have a role in pharmacological closure of PDA (Patent arterial duct) in preterm infants. The investigators conducted this open label non randomized and non control study to try to support that report.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPDA
CountriesIsrael
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 2012
Enrollment StartJan 2013
Primary CompletionDec 2018
TodayJul 2026
First PostedDec 24, 2012
Enrollment StartJan 1, 2013
Primary CompletionDec 31, 2018
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 13.5 years ago
Interventions
Paracetamoldrug
Per gavage paracetamol 15 mg/kg every 6 hours, for up to 7 days.
Ibuprofendrug
Per Gavage ibuprofen 10mg/kg x 3/d for up to 5 days Gold standard per literature
Closure of PDAprocedure
Open surgery for closure of PDA