Alternative Paracetamol Treatments for the Neonate With a hsPDA

Phase 2

• Conditions: Ductus Arteriosus, Patent
• Interventions: Drug: Intravenous Infusion; Drug: Rectal Solution

• Registration Number: NCT03604796
• Lead Sponsor: Shaare Zedek Medical Center

Brief 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.

Study Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-07-19
• Study First Submitted QC: 2018-07-19
• Last Update Submitted: 2018-07-19
• Study First Posted: 2018-07-30
• Last Update Posted: 2018-07-30
• Study Start: 2018-09
• Primary Completion: 2021-09
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Inborn preterm neonates, < 1000 gm birth weight; < 28 weeks' gestational age; who are admitted to the neonatal intensive care unit of the Shaare Zedek Medical Center and are diagnosed with a hemodynamically significant patent ductus arteriosus within the first week of life and who are on limited or no enteral feeds -

Exclusion Criteria

Other congenital heart disease, major congenital anomalies, sepsis; and/or NEC.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous IV Acetaminophen	Intravenous Infusion	Intravenous Infusion
Rectal Acetaminophen	Rectal Solution	Rectal Solution

Primary Outcome Measures

Name	Time	Method
Ductal closure	Up to 1 week following treatment	Follow-up echocardiogram showing closed ductus arteriosus

Secondary Outcome Measures

Name	Time	Method
PDA Ligation	Completion of study intervention until 40 weeks post-conception	Need for surgical ligation

Trial Locations

Locations (1)

Neonatal Intensive Care Unit - Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel