Comparison · NCT00307333-sae
Intervention vs Control: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Intervention vs Control: serious adverse events. Trial comparisons, record NCT00307333-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00307333-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 | 0.0813 | 0.0685 | 0.0963 | wilson | |
| Risk in group 2 | 0.102 | 0.0877 | 0.118 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0207 | -0.0416 | -0.0000307 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.797 | 0.635 | 1 | log | |
| Odds ratio, group 1 over group 2 | 0.779 | 0.607 | 1 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Intervention than on Control | 48.2 | 24.1 | 32,600 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Intervention | Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan. | 122 | 1,500 | EG000 |
| Group 2 | Control | Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment. | 152 | 1,489 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 120 days follow-up
Source ClinicalTrials.gov
Trial
- Title
- Impact of Heart Rate Characteristics Monitoring in Neonates
- NCT number
- NCT00307333
- Phases
- NA
- Conditions
- Sepsis
- Interventions
- HeRO heart rate characteristics monitor
- Lead sponsor
- University of Virginia
- Results first posted
- 2013-05-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00307333?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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