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Alternative Paracetamol Treatments for the Neonate With a hsPDA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03604796
Recruitment Status : Not yet recruiting
First Posted : July 30, 2018
Last Update Posted : July 30, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ductus Arteriosus, Patent Drug: Rectal Solution Drug: Intravenous Infusion Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Continuous IV Acetaminophen
Intravenous Infusion
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
Other Name: acetaminophen / paracetamol

Active Comparator: Rectal Acetaminophen
Rectal Solution
Drug: Rectal Solution
Rectal acetaminophen at 15 mg/kg x 4/day for three days
Other Name: acetaminophen / paracetamol

Primary Outcome Measures :
  1. Ductal closure [ Time Frame: Up to 1 week following treatment ]
    Follow-up echocardiogram showing closed ductus arteriosus

Secondary Outcome Measures :
  1. PDA Ligation [ Time Frame: Completion of study intervention until 40 weeks post-conception ]
    Need for surgical ligation

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 10 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03604796

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Contact: Cathy Hammerman, MD 0508685238
Contact: Alona Bin-Nun, MD 0508685757

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Neonatal Intensive Care Unit - Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
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Principal Investigator: Cathy Hammerman, MD Shaare Zedek Medical Center
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Responsible Party: Shaare Zedek Medical Center Identifier: NCT03604796    
Other Study ID Numbers: 0207-18-SZMC
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shaare Zedek Medical Center:
Additional relevant MeSH terms:
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Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs