Alternative Paracetamol Treatments for the Neonate With a hsPDA

NCT ID: NCT03604796

Last Updated: 2018-07-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-30
• Study Completion Date: 2022-01-31

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.

Conditions

Ductus Arteriosus, Patent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Continuous IV Acetaminophen

Intravenous Infusion

Group Type: ACTIVE_COMPARATOR

Intravenous Infusion

Intervention Type: DRUG

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

Rectal Acetaminophen

Rectal Solution

Group Type: ACTIVE_COMPARATOR

Rectal Solution

Intervention Type: DRUG

Rectal acetaminophen at 15 mg/kg x 4/day for three days

Interventions

Rectal Solution

Rectal acetaminophen at 15 mg/kg x 4/day for three days

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

acetaminophen / paracetamol; acetaminophen / paracetamol

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Days
• Maximum Eligible Age: 10 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaare Zedek Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cathy Hammerman, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center

Locations

Neonatal Intensive Care Unit - Shaare Zedek Medical Center

Jerusalem, , Israel

Countries

Israel

Central Contacts

Cathy Hammerman, MD

Role: CONTACT

cathyh@ekmd.huji.ac.il

0508685238

Alona Bin-Nun, MD

Role: CONTACT

alonabinnun@szmc.org.il

0508685757

Other Identifiers

0207-18-SZMC

Identifier Type: -

Identifier Source: org_study_id