Randomized Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infan… (NCT03701074) | Clinical Trial Compass
TerminatedPhase 2
Randomized Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus
Stopped: very slow enrollment. Only one patient enrolled. Termination by PI
United States1 participantsStarted 2018-12-15
Plain-language summary
The purpose of the present study is to determine whether treatment of hemodynamically significant patent ductus arteriosus with a combined therapy of intravenous Ibuprofen and oral acetaminophen has higher success rate in closing the ductus arteriosus than a standard treatment strategy of using intravenous ibuprofen alone among preterm infants.
Who can participate
Age range5 Days – 21 Days
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Preterm infant ≤27 6/7
✓. Written parental consent is obtained
✓. Infant requires respiratory support
✓. diagnosis of a persistent patent ductus arteriosus after 5 days of age, (defined as at least two of the following:
✓. Ductus size ≥ 1.5 mm
✓. Maximum flow velocity through the ductus ≤ 2 m/s
✓. Left atrium to aorta ratio ≥ 1.4
✓. Wide pulse pressure
Exclusion criteria
✕. No parental consent
✕. Infants \> 21days of postnatal age
✕. Congenital anomalies such as cardiac or multiple anomalies
✕
What they're measuring
1
Proportion of Participants With Ductus Arteriosus Closure/Constriction
Timeframe: 24-48 hours after the completion of study intervention