Role of Vitamin D Therapy in Recovery From Early Neonatal Sepsis (Randomized Controlled Trial)
Model scores of the 29,894 trials active now.
Model score 5% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (741 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-12-27, after 2018-08-14 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 2022-12-27. 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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Sponsor's past termination rate: 0.7% (lowers risk) · Sponsor's track record
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Design: factorial (lowers risk) · Design
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Drug's FAERS reports marked serious: 52.5% (lowers risk) · Drug's FDA history
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Phase: 3 (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: sepsiscarebirthstudy isneonatal
Phrases that lowered it: evaluate theblood400unitsclinical -
Sponsor type: academic or other (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 176 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: not given (lowers risk) · Design
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Minimum age: 0.01 (lowers risk) · Who can join
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Drug's FAERS reports with a death: 5.1% (lowers risk) · Drug's FDA history
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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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Number of arms: 3 (lowers risk) · Design
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Maximum age: 0.02 (raises risk) · Who can join
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Drug's FAERS reports before start: 18312 (raises risk) · Drug's FDA history
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Sponsor's past trials: 146 (lowers risk) · Sponsor's track record
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
- 3 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- factorial (typical: parallel)
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 0.01 (typical: 18)
- Maximum age
- 0.02 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 146 (typical: 32)
- Sponsor's past termination rate
- 0.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 176 (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
- 18312 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3188 (typical: 412.5)
- Drug's FAERS reports marked serious
- 52.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- vitamin d
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
- A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis NCT02273843 · started 2013 · scored riskier than 12% of active trials completed
- Vitamin D to Improve Outcomes by Leveraging Early Treatment NCT03096314 · started 2017 · scored riskier than 94% of active trials completed
- Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis NCT01689441 · started 2013 · scored riskier than 79% of active trials completed
- Oral Vitamin A Supplementation for Prevention of Bronchopulmonary Dysplasia in Preterm Infants NCT07577180 · started 2012 · scored riskier than 11% of active trials completed
- Cholecalciferol Supplementation in Critically Ill Patients With Severe Vitamin D Deficiency. NCT02868827 · started 2017 · scored riskier than 44% 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.