NCT03604796

Alternative Paracetamol Treatments for the Neonate With a hsPDA

Alternative Acetaminophen Treatment of the Hemodynamivally Significant Patent Ductus Arteriosus in Preterm Neonates Who Are Not Candidates for Enteral Administration: A Pilot Study

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Shaare Zedek Medical Center · Academic / Other
• Sex: All
• Age: 2 Days – 10 Days
• Healthy volunteers: Not accepted

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.

Detailed description

Once parental consent for entrance into the study is obtained, eligible babies will be randomized to receive either IV acetaminophen (perfalgen) by continuous infusion at 2.5 mg/kg/h following a loading dose of 15 mg /kg/ over 20 minutes or rectal acetaminophen at 15 mg/kg every 6 hours for a period of 3 days.

Conditions

• Ductus Arteriosus, Patent

Interventions

Type	Name	Description
DRUG	Rectal Solution	Rectal acetaminophen at 15 mg/kg x 4/day for three days
DRUG	Intravenous Infusion	Loading dose of 15 mg/kg IV acetaminophen followed by a continuous infusion at a rate of 2.5 mg/kg/hr for 72 hours

Timeline

• Start date: 2018-09-01
• Primary completion: 2021-09-01
• Completion: 2022-01-01
• First posted: 2018-07-30
• Last updated: 2018-07-30

Locations

1 site across 1 country: Israel