Alternative Paracetamol Treatments for the Neonate With a hsPDA

Ductus Arteriosus, Patent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03604796
• Other study ID #: 0207-18-SZMC
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: September 2018
• Est. completion date: January 2022

Study information

• Verified date: July 2018
• Source: Shaare Zedek Medical Center
• Contact: Cathy Hammerman, MD
• Phone: 0508685238
• Email: cathyh[@]ekmd.huji.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: January 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Days

Eligibility

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.

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent

Intervention

Drug:
• Rectal Solution
Rectal acetaminophen at 15 mg/kg x 4/day for three days
• 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

Locations

Country	Name	City	State
Israel	Neonatal Intensive Care Unit - Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ductal closure	Follow-up echocardiogram showing closed ductus arteriosus	Up to 1 week following treatment
Secondary	PDA Ligation	Need for surgical ligation	Completion of study intervention until 40 weeks post-conception