Comparison · NCT02951130-sae
Milrinone vs 5% dextrose (D5W): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Milrinone vs 5% dextrose (D5W): serious adverse events. Trial comparisons, record NCT02951130-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02951130-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.152 | 0.0665 | 0.309 | wilson | |
| Risk in group 2 | 0.0909 | 0.0314 | 0.236 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0606 | -0.107 | 0.229 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.67 | 0.433 | 6.41 | log | |
| Odds ratio, group 1 over group 2 | 1.79 | 0.39 | 8.17 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Milrinone than on 5% dextrose (D5W) | 16.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Milrinone | Milrinone infusion at 0.33µg/kg/min. The dose of the study drug will be increased to 0.66 µg/kg/min if oxygenation index (OI) remains ≥ 10 without any evidence of hypotension (as defined by the protocol) two hours after initiation of study drug. Infusion will be continued until the OI decreases to \< 7. The maximum duration of study drug infusion is 72 hours. | 5 | 33 | EG000 |
| Group 2 | 5% dextrose (D5W) | An equivalent volume of 5% dextrose (D5W) will be used for infants randomized to the placebo arm. | 3 | 33 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Study specified adverse events (AE) are monitored during the study (e.g. from treatment initiation through 24 hours after discontinuation of study drug infusion).
Source ClinicalTrials.gov
Trial
- Title
- Milrinone in Congenital Diaphragmatic Hernia
- NCT number
- NCT02951130
- Phases
- PHASE2
- Conditions
- Congenital Diaphragmatic Hernia, Persistent Pulmonary Hypertension of the Newborn, Hypoxemic Respiratory Failure, Pulmonary Hypoplasia
- Interventions
- Milrinone, Placebo (5% Dextrose)
- Lead sponsor
- NICHD Neonatal Research Network
- Results first posted
- 2025-11-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02951130?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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