Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 21% of the time (143 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2025-01-15, after 2021-05-27 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2025-01-15. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: randomizationhoursventilationinfants24
Phrases that lowered it: participantsafety ofnasalexposureinvestigator -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
-
Number of arms: 6 (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
-
Design: parallel (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 15.9% (lowers risk) · Drug's FDA history
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Responsible party: sponsor investigator (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: not given (raises risk) · Who can join
-
Blinding: quadruple (lowers risk) · Design
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Drug's FAERS reports marked serious: 67.2% (lowers risk) · Drug's FDA history
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Maximum age: 0.56 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Collaborators: 2 (lowers risk) · Design
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Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Disease area, respiratory: Yes (raises risk) · Disease area
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Drug's FAERS reports in the prior 12 months: 6926 (lowers 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
- Number of arms
- 6 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- not given (typical: 18)
- Maximum age
- 0.56 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 99662 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6926 (typical: 412.5)
- Drug's FAERS reports marked serious
- 67.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 15.9%
Disease area and drugs
- Disease areas
- respiratory
- Drugs matched to FDA substances
- sildenafil
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
- Safety of Sildenafil in Premature Infants NCT03142568 · started 2018 · scored riskier than 52% of active trials completed
- PNEUMOSTEM for the Prevention and Treatment of Severe BPD in Premature Infants NCT03392467 · started 2018 · scored riskier than 24% of active trials completed
- Inhaled Tobramycin in BPD NCT04560179 · started 2022 · scored riskier than 33% of active trials completed
- Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of BPD in Premature Infants NCT01828957 · started 2013 · scored riskier than 22% of active trials completed
- Safety and Efficacy of PNEUMOSTEM® in Premature Infants at High Risk for Bronchopulmonary Dysplasia (BPD) - a US Study NCT02381366 · started 2015 · scored riskier than 55% of active trials completed
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.