drugset / Trial / NCT03604796

Alternative Paracetamol Treatments for the Neonate With a hsPDA

NCT03604796

Phase 2/3 Unknown 80 enrolled Shaare Zedek Medical Center
RandomizedParallel-groupSingle-blindTreatment

Summary

Early targeted treatment of a hemodynamically significant patent ductus arteriosus (hsPDA) during the first week of life in preterm neonates is often recommended. Our standard first line therapeutic approach is enteral acetaminophen. However many extremely low birth weight infants may be on limited or no feeds when PDA closure is determined to be indicated, thus restricting the use of enteral acetaminophen. Several studies have suggested that intravenous acetaminophen is less effective than enteral. Thus, in this study, we propose to compare two alternative modes of administration when enteral acetaminophen is not an option.

Timeline

Start
2018-09
Primary completion
2021-09
Completion
2022-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 2.5 mg/kg Rectal
Comparator Acetaminophen Small molecule 15 mg/kg Rectal