An Escalating Dose Indomethacin for the Treatment of Persistent Patent Ductus Arteriosus (PDA) In Preterm Infants
Model scores of the 29,894 trials active now.
Model score 10% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (107 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Terminated on 2013-01-31, after 2008-08-31 start.
Reason given by the sponsor: “other”
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2013-01-31. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: failuregradeevidence ofheartdisease
Phrases that lowered it: use ofweightstudydoseresult -
Sponsor's past termination rate: 5% (lowers risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Design: parallel (raises risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 29 (lowers risk) · Sponsor's track record
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Phase: 2/3 (raises risk) · Design
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Drug's FAERS reports with a death: 13.8% (lowers risk) · Drug's FDA history
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Maximum age: 0.08 (raises risk) · Who can join
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Responsible party: principal investigator (lowers risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Minimum age: not given (raises risk) · Who can join
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Disease area, cancer: No (lowers risk) · Disease area
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Number of arms: 2 (raises risk) · Design
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Drug's FAERS reports marked serious: 87.1% (raises risk) · Drug's FDA history
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2/3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- not given (typical: 18)
- Maximum age
- 0.08 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 20 (typical: 32)
- Sponsor's past termination rate
- 5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 29 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 1707 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 368 (typical: 412.5)
- Drug's FAERS reports marked serious
- 87.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 13.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- indomethacin
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- High-dose Ibuprofen for Patent Ductus Arteriosus (PDA) in Preterm Infant NCT01243996 · started 2008 · scored riskier than 16% of active trials completed
- Oral Ibuprofen Versus Placebo in Treatment of Patent Ductus Arteriosus (PDA)in Preterm Infants NCT05493540 · started 2021 · scored riskier than 44% of active trials completed
- Randomized Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus NCT03701074 · started 2018 · scored riskier than 92% of active trials terminated
- Acetaminophen vs Indomethacin in Treating hsPDA NCT03537144 · started 2016 · scored riskier than 64% of active trials terminated
- Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus NCT03648437 · started 2018 · scored riskier than 18% of active trials terminated
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.