- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04025177
Indomethacin PK-PD in Extremely Preterm Neonates (INDO)
September 28, 2021 updated by: University of Manitoba
Pharmacokinetics and Pharmacodynamics of Indomethacin Used for PDA Treatment in Extremely Preterm Neonates <27 Weeks Gestational Age
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.
Study Overview
Status
Withdrawn
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Manitoba
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Winnipeg, Manitoba, Canada, R3A 1R9
- Health Sciences Centre
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Winnipeg, Manitoba, Canada, R2H 2A6
- St. Boniface General Hospital Research Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 months to 5 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Neonates with an open PDA
Neonates born between 23 (0/7) and 26 (6/7) weeks gestational age with an open PDA, according to clinical protocol criteria, and no contraindication to the use of indomethacin.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the curve from serial Indomethacin levels
Time Frame: At 48 hour following the last dose
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Blood samples will be drawn from patients to determine the serum indomethacin levels to determine the area under the curve
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At 48 hour following the last dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants with Patent Ductus Arteriosus Closure
Time Frame: Within 48 hrs after the last dose
|
Confirmed by echocardiogram
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Within 48 hrs after the last dose
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Percentage of Participants with Intraventricular hemorrhage
Time Frame: Within the first 7 days of life.
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Confirmed by cranial ultrasound performed and graded using Papile's classification system
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Within the first 7 days of life.
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Duration of mechanical ventilation of each patient
Time Frame: trough hospital discharge, an average of up to 36 weeks gestational age
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Number of days the infant was intubated and ventilated.
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trough hospital discharge, an average of up to 36 weeks gestational age
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Percentage of Participants with Adverse Events
Time Frame: trough hospital discharge, an average of up to 36 weeks gestational age
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development of any type A adverse reactions in the infants receiving indomethacin therapy
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trough hospital discharge, an average of up to 36 weeks gestational age
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Deepak Louis, MD, University of Manitoba
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2020
Primary Completion (Anticipated)
August 1, 2021
Study Completion (Anticipated)
February 1, 2022
Study Registration Dates
First Submitted
May 27, 2019
First Submitted That Met QC Criteria
July 16, 2019
First Posted (Actual)
July 18, 2019
Study Record Updates
Last Update Posted (Actual)
October 6, 2021
Last Update Submitted That Met QC Criteria
September 28, 2021
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Congenital Abnormalities
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Premature Birth
- Ductus Arteriosus, Patent
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Reproductive Control Agents
- Gout Suppressants
- Tocolytic Agents
- Indomethacin
Other Study ID Numbers
- B2018:095
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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