Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 9% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 11% of the time (130 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 2016-03-31, after 2012-05-31 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 2016-03-31. 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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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: breastenrollmentto determinecompletedchronic
Phrases that lowered it: evaluate theto evaluatepharmacokineticsperiodreflux -
Phase: 2 (raises risk) · Design
-
Blinding: quadruple (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 36 (lowers risk) · Sponsor's track record
-
Sponsor's past termination rate: 5.4% (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 16.1% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 96.9% (raises risk) · Drug's FDA history
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Sponsor's past trials: 56 (lowers risk) · Sponsor's track record
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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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Number of arms: 2 (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.
The trial
Design
- Phase
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 45 (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 56 (typical: 32)
- Sponsor's past termination rate
- 5.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 36 (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
- 2542 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 612 (typical: 412.5)
- Drug's FAERS reports marked serious
- 96.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 16.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- Drugs matched to FDA substances
- domperidone
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
- Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants NCT01534481 · started 2012 · scored riskier than 87% of active trials completed
- A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women NCT05632393 · started 2023 · scored riskier than 4% of active trials completed
- Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely NCT02545127 · started 2021 · scored riskier than 52% of active trials terminated
- Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan NCT05547100 · started 2022 · scored riskier than 3% of active trials completed
- Efficacy of ASIMOMMY® Compared to Domperidone and Placebo in Increasing Breastfeeding: Randomized Single-Blind Controlled Trial in Indonesia NCT05596006 · started 2022 · scored riskier than 5% 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.