Effects of Delayed Cord Clamp and/or Indomethacin on Preterm Infant Brain Injury
Model scores of the 29,894 trials active now.
Model score 13% 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 17% of the time (106 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 2021-08-28, after 2014-08-31 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 2021-08-28. 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: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: brainlongbirthpatientlife
Phrases that lowered it: identified bycurrentinvestigatorsinterventionrandomized -
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Phase: 1/2 (raises risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Responsible party: sponsor investigator (raises risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 0.46 (lowers risk) · Who can join
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Number of arms: 4 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 12.5% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Maximum age: 0.58 (raises risk) · Who can join
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Collaborators: 1 (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Primary purpose: prevention (lowers risk) · Design
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Drug's FAERS reports marked serious: 81.6% (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
- 1/2 (typical: 2)
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 0.46 (typical: 18)
- Maximum age
- 0.58 (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
- 4790 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 518 (typical: 412.5)
- Drug's FAERS reports marked serious
- 81.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, neurology
- 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
- Management of Hypotension In the Preterm Infant NCT01482559 · started 2015 · scored riskier than 57% of active trials terminated
- Extremely Low Gestatonal Age Infants' Paracetamol Study NCT03641209 · started 2018 · scored riskier than 29% of active trials completed
- Early Blood Pressure Management in Extremely Premature Infants NCT00874393 · started 2009 · scored riskier than 35% of active trials completed
- A Multi-site Study of Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy NCT02612155 · started 2017 · scored riskier than 95% of active trials completed
- A Study of 2-Iminobiotin in Neonates With Perinatal Asphyxia NCT01626924 · started 2012 · scored riskier than 33% 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.