The Use of Methadone in Newborn Infants
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 11% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (45 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
Completed on 2017-12-31, after 2010-12-31 start.
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 2017-12-31. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: stagepainopioidusetreatment of
Phrases that lowered it: pkdosingadverseleadclinical -
Accepts healthy volunteers: No (raises risk) · Who can join
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Drug's FAERS reports with a death: 39.5% (raises risk) · Drug's FDA history
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Phase: 1/2 (raises risk) · Design
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Responsible party: sponsor investigator (raises risk) · Design
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: Yes (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Maximum age: 0.83 (raises risk) · Who can join
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Minimum age: 0.42 (lowers risk) · Who can join
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Blinding: none (raises risk) · Design
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Number of arms: 2 (raises risk) · Design
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Drug's FAERS reports marked serious: 86.2% (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
- 1/2 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- single group (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 0.42 (typical: 18)
- Maximum age
- 0.83 (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
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 7808 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1746 (typical: 412.5)
- Drug's FAERS reports marked serious
- 86.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 39.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- Drugs matched to FDA substances
- inulin, methadone, sinistrin
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
- Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure NCT03608696 · started 2018 · scored riskier than 47% of active trials completed
- Measuring the Amount of Methadone or Morphine in the Blood of Neonates, Infants & Children After Cardiac Surgery. NCT01094522 · started 2010 · scored riskier than 79% of active trials completed
- Single Dose IV Methadone for Post-Op Pain NCT05425420 · started 2023 · scored riskier than 4% of active trials completed
- Codeine in Mechanically Ventilated Neonates NCT01322204 · started 2008 · scored riskier than 69% of active trials completed
- Fetal and Infant Effects of Maternal Buprenorphine Treatment NCT01561079 · started 2012 · scored riskier than 38% 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.