Alternative Paracetamol Treatments for the Neonate With a hsPDA

Status Not yet recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Ductus Arteriosus, Patent

Clinical Trial Details

NCT number	NCT03604796
Study type	Interventional
Source	Shaare Zedek Medical Center
Contact	Cathy Hammerman, MD
Phone	0508685238
Email	cathyh@ekmd.huji.ac.il
Status	Not yet recruiting
Phase	Phase 2/Phase 3
Start date	September 2018
Completion date	January 2022

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT00828334` - NIT-OCCLUD PDA Phase II Sentinel Trial	N/A
Completed	`NCT00009646` - Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)	Phase 3
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Completed	`NCT00725647` - Plasma N-terminal proBNP Concentrations and Patent Ductus Arteriosus in Preterm Babies	N/A
Terminated	`NCT00239512` - New Management Strategy of PDA for VLBW Preterm Infants	N/A
Recruiting	`NCT04508036` - Ductus Arteriosus Closure and D-Dimer and Fibrinogen Levels
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Not yet recruiting	`NCT04205877` - The U.S. PDA Registry
Recruiting	`NCT05547165` - Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants	N/A
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Completed	`NCT02803671` - Analysis of the Impact of Patent Ductus Arteriosus on Brain Function in Preterm Neonates: Multimodal Approach Integrating EEG-NIRS, Ultrasound and Clinical Data	N/A
Completed	`NCT00799123` - Urine NT-proBNP Levels and Echocardiographic Findings in Very Low Birth Weight (VLBW) Infants	N/A
Completed	`NCT00528736` - Plasma B-Type Natriuretic Peptide Concentrations in Preterm Infants < 28 Weeks	N/A
Completed	`NCT02002741` - Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants	Phase 2/Phase 3