Comparison · NCT00515281-sae
INO Control (Short iNO) vs INO Treatment (Long iNO): 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. INO Control (Short iNO) vs INO Treatment (Long iNO): serious adverse events. Trial comparisons, record NCT00515281-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00515281-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 | 0.384 | 0.307 | 0.467 | wilson | |
| Risk in group 2 | 0.452 | 0.37 | 0.536 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0678 | -0.182 | 0.0487 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.85 | 0.642 | 1.13 | log | |
| Odds ratio, group 1 over group 2 | 0.756 | 0.467 | 1.23 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on INO Control (Short iNO) than on INO Treatment (Long iNO) | 14.8 | 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 | INO Control (Short iNO) | INO will be given to infants in the control group for the first 7 days of the study gas, then O2 or room air, as clinically appropriate, on the 8th day, until 33 weeks corrected age~inhaled nitric oxide: The amount of gas will be carefully controlled and adjusted to the level that best improves the function of subject's lungs. The subject will remain on inhaled nitric oxide until he/she reaches 33 weeks of gestation if assigned to the treatment arm, or until the 8th day of the study if he/she is assigned to the control arm. | 53 | 138 | EG000 |
| Group 2 | INO Treatment (Long iNO) | The treatment group will receive iNO, combined with O2 or room air, until 33 weeks corrected age.~inhaled nitric oxide: The amount of gas will be carefully controlled and adjusted to the level that best improves the function of subject's lungs. The subject will remain on inhaled nitric oxide until he/she reaches 33 weeks of gestation if assigned to the treatment arm, or until the 8th day of the study if he/she is assigned to the control arm.~oxygen: The amount of gas will be carefully controlled and adjusted to the level that best improves the function of the subject's lungs. Subjects in the control arm of the study will receive oxygen beginning on the 8th day of the study until he/she reaches 33 weeks of gestation. | 61 | 135 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- through discharge (up to 400 days)
Source ClinicalTrials.gov
Trial
- Title
- Inhaled Nitric Oxide and Neuroprotection in Premature Infants
- NCT number
- NCT00515281
- Phases
- PHASE2, PHASE3
- Conditions
- Prematurity, Bronchopulmonary Dysplasia, Intraventricular Hemorrhage, Periventricular Leukomalacia
- Interventions
- inhaled nitric oxide, oxygen
- Lead sponsor
- University of Chicago
- Results first posted
- 2024-10-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00515281?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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