Buprenorphine for Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 12% of the time (145 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 2016-09-30, after 2012-08-31 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 2016-09-30. 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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Sponsor's past termination rate: 21.2% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1 (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: syndromebreast30 daysintravenousbirth
Phrases that lowered it: sublingualtrialinvestigate theexposureopen label -
Drug's FAERS reports with a death: 26.8% (raises risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 18 (lowers risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports in the prior 12 months: 6963 (lowers risk) · Drug's FDA history
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Maximum age: not given (raises risk) · Who can join
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Disease area, neurology: No (lowers risk) · Disease area
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Collaborators: 0 (raises risk) · Design
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Drug's FAERS reports marked serious: 90.2% (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 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- not given (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 33 (typical: 32)
- Sponsor's past termination rate
- 21.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 18 (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
- 32544 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6963 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 26.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- buprenorphine, morphine
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
- Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome NCT01452789 · started 2011 · scored riskier than 72% of active trials completed
- Comparison of Buprenorphine to Morphine in Treatment of Neonatal Abstinence Syndrome (NAS) NCT01708707 · started 2012 · scored riskier than 46% of active trials completed
- Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure NCT03608696 · started 2018 · scored riskier than 47% of active trials completed
- Maternal Buprenorphine-naloxone Treatment and the Infant NCT03291847 · started 2018 · scored riskier than 48% of active trials completed
- Can Ondansetron Prevent Neonatal Abstinence Syndrome (NAS) in Babies Born to Narcotic-dependent Women NCT01965704 · started 2014 · scored riskier than 58% 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.