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Indomethacin PK-PD in Extremely Preterm Neonates | Clinical Trials | Clareo Health

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Indomethacin PK-PD in Extremely Preterm Neonates

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

NCT04025177•University of Manitoba

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female infant born between 23 (0/7) and 26 (6/7) week GA
•Infant diagnosed with PDA according to clinical protocol criteria
•Able to adhere to indomethacin administration protocol
•The patient is born in the study center.
•Subject's parent(s)/legal guardian(s) has provided signed and dated informed consent and authorization to use protected health information, as required by national and local regulations.
•In the investigator's opinion, the subject's parent(s)/legal guardian(s) understand(s) and can comply with protocol requirements, instructions, and protocol-stated restrictions, and is likely to complete the study as planned.

Exclusion Criteria

•known major congenital malformations (renal, cardiac, gastrointestinal and central nervous system)
•genetic syndromes-inborn errors of metabolism
•severe renal compromise
•intrauterine growth retardation with birth weight \<3rd centile
•thrombocytopenia \<50,000/mm3
•moderate to severe pulmonary hypertension
•clinical sepsis -meningitis- hepatitis
•anticipated drug-drug-interactions (specifically CYP2C9, CYP2C19 and UGT 1-1)

Locations (2)

St. Boniface General Hospital Research Centre

Winnipeg, Manitoba, Canada

Health Sciences Centre

Winnipeg, Manitoba, Canada

Key Dates

Start Date

January 1, 2020

Primary Completion Date

August 1, 2021

Completion Date

February 1, 2022

Last Updated

October 6, 2021

Conditions

Patent Ductus Arteriosus After Premature Birth

Interventions

Indomethacin Injection

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 6, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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