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Indomethacin PK-PD in Extremely Preterm Neonates — INDO  

Patent Ductus Arteriosus After Premature Birth Clinical Trial

Official title:
Pharmacokinetics and Pharmacodynamics of Indomethacin Used for PDA Treatment in Extremely Preterm Neonates <27 Weeks Gestational Age

Clinical Trial Summary

This is a phase II open-label study evaluating the pharmacokinetics and pharmacodynamics of targeted early use of indomethacin for PDA treatment in preterm neonates <27 weeks' gestational age.

Clinical Trial Description

Neonates will be enrolled following an echocardiogram performed within 12 hours after birth that confirms an open PDA (with no other contraindications for indomethacin treatment). After enrollment, neonates will receive intravenous indomethacin at a dose of 0.1mg/kg every 24 hours for 3 days. Indomethacin levels will be measured at regular intervals. Urine output and serum electrolytes will be monitored prior to each dose of indomethacin. An echocardiogram will be repeated after completion of indomethacin treatment (between 72-120 hours of age) to reassess the status of PDA. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04025177
Study type Interventional
Source University of Manitoba
Contact
Status Withdrawn
Phase Phase 2
Start date January 2020
Completion date February 2022
View Details
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