A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC)

Model scores of the 29,894 trials active now.

Model score 11% 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 10% of the time (528 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2018-05-24. 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.

• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: study entrypriorpretermtermbirth
  Phrases that lowered it: alfaefficacyinvestigate theand safetyto investigate
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 2.8% (lowers risk) · Sponsor's track record
• Phase: 2 (raises risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Drug's FAERS reports with a death: 41.1% (raises risk) · Drug's FDA history
• Design: parallel (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Minimum age: not given (raises risk) · Who can join
• Number of arms: 2 (raises risk) · Design
• Drug's FAERS reports marked serious: 97.7% (raises risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 17 (lowers risk) · Sponsor's track record
• Disease area, neurology: No (lowers risk) · Disease area
• Maximum age: not given (lowers risk) · Who can join
• Sponsor's past trials: 72 (lowers risk) · Sponsor's track record
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Blinding: double (raises risk) · Design
• Drug's FAERS reports before start: 129 (lowers risk) · Drug's FDA history
• Collaborators: 0 (raises risk) · Design

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.

• A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration NCT02772081 · started 2021 · scored riskier than 30% of active trials terminated
• A Study To InvestigateThe Safety, Tolerability And Efficacy Of Nebulised Curosurf® In Preterm Neonates With Respiratory Distress Syndrome (RDS) NCT03235986 · started 2017 · scored riskier than 16% of active trials terminated
• First In Human Study on Synthetic Surfactant CHF 5633 in Respiratory Distress Syndrome NCT01651637 · started 2012 · scored riskier than 13% of active trials completed
• A Clinical Safety Study of AT-100 (rhSP-D) in Preterm Neonates at High Risk for Bronchopulmonary Dysplasia (BPD) NCT04662151 · started 2021 · scored riskier than 54% of active trials completed
• Aerosolized Surfactant in Neonatal RDS NCT02294630 · started 2014 · scored riskier than 74% 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.