WithdrawnPhase 2

Indomethacin PK-PD in Extremely Preterm Neonates

Stopped: Halted due to feasibility issues

Canada0Started 2020-01

Plain-language 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.

Who can participate

Age range

23 Weeks – 26 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area under the curve from serial Indomethacin levels

Timeframe: At 48 hour following the last dose

Trial details

NCT IDNCT04025177

SponsorUniversity of Manitoba

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08

View on ClinicalTrials.gov More Patent Ductus Arteriosus After Premature Birth trials

Who can participate

Age range

23 Weeks – 26 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.