Alternative Paracetamol Treatments for the Neonate With a hsPDA

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ductus Arteriosus, Patent

Intervention / Treatment
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* Drug: Rectal Solution
* Drug: Intravenous Infusion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 10 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous IV Acetaminophen<br>Intravenous Infusion | Drug: Intravenous Infusion<br>* 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<br>* Other names: acetaminophen / paracetamol;|
| Active Comparator: Rectal Acetaminophen<br>Rectal Solution | Drug: Rectal Solution<br>* Rectal acetaminophen at 15 mg/kg x 4/day for three days<br>* Other names: acetaminophen / paracetamol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ductal closure | Follow-up echocardiogram showing closed ductus arteriosus | Up to 1 week following treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PDA Ligation | Need for surgical ligation | Completion of study intervention until 40 weeks post-conception | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acetaminophen