NCT04025177

Indomethacin PK-PD in Extremely Preterm Neonates

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 23 Weeks – 26 Weeks
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Patent Ductus Arteriosus After Premature Birth

Interventions

Type	Name	Description
DRUG	Indomethacin Injection	The dose of indomethacin will be 0.1 mg/kg/dose, based on birth weight, intravenously every 24 hours for a total of 3 doses. Doses 2 and 3 may be administered between 23.5 and 24.5 hours after the previous dose. Doses will be rounded to two significant figures.

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-08-01
• Completion: 2022-02-01
• First posted: 2019-07-18
• Last updated: 2021-10-06

Locations

2 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study