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Alternative Paracetamol Treatments for the Neonate With a hsPDA

Primary Purpose

Ductus Arteriosus, Patent

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Rectal Solution
Intravenous Infusion
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ductus Arteriosus, Patent focused on measuring acetaminophen

Eligibility Criteria

2 Days - 10 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Neonatal Intensive Care Unit - Shaare Zedek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Continuous IV Acetaminophen

Rectal Acetaminophen

Arm Description

Intravenous Infusion

Rectal Solution

Outcomes

Primary Outcome Measures

Ductal closure
Follow-up echocardiogram showing closed ductus arteriosus

Secondary Outcome Measures

PDA Ligation
Need for surgical ligation

Full Information

First Posted
July 19, 2018
Last Updated
July 19, 2018
Sponsor
Shaare Zedek Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03604796
Brief Title
Alternative Paracetamol Treatments for the Neonate With a hsPDA
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2018 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shaare Zedek Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ductus Arteriosus, Patent
Keywords
acetaminophen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous IV Acetaminophen
Arm Type
Active Comparator
Arm Description
Intravenous Infusion
Arm Title
Rectal Acetaminophen
Arm Type
Active Comparator
Arm Description
Rectal Solution
Intervention Type
Drug
Intervention Name(s)
Rectal Solution
Other Intervention Name(s)
acetaminophen / paracetamol
Intervention Description
Rectal acetaminophen at 15 mg/kg x 4/day for three days
Intervention Type
Drug
Intervention Name(s)
Intravenous Infusion
Other Intervention Name(s)
acetaminophen / paracetamol
Intervention Description
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
Primary Outcome Measure Information:
Title
Ductal closure
Description
Follow-up echocardiogram showing closed ductus arteriosus
Time Frame
Up to 1 week following treatment
Secondary Outcome Measure Information:
Title
PDA Ligation
Description
Need for surgical ligation
Time Frame
Completion of study intervention until 40 weeks post-conception

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Days
Maximum Age & Unit of Time
10 Days
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cathy Hammerman, MD
Phone
0508685238
Email
cathyh@ekmd.huji.ac.il
First Name & Middle Initial & Last Name or Official Title & Degree
Alona Bin-Nun, MD
Phone
0508685757
Email
alonabinnun@szmc.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cathy Hammerman, MD
Organizational Affiliation
Shaare Zedek Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neonatal Intensive Care Unit - Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

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Alternative Paracetamol Treatments for the Neonate With a hsPDA

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