Comparison · NCT01751724-ae349028
Caffeine Arm vs Placebo Arm: Number of Infants With Severe Intraventricular Hemorrhage
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. Caffeine Arm vs Placebo Arm: Number of Infants With Severe Intraventricular Hemorrhage. Trial comparisons, record NCT01751724-ae349028. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01751724-ae349028
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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 | 0.293 | 0.176 | 0.445 | wilson | |
| Risk in group 2 | 0.143 | 0.0672 | 0.278 | wilson | |
| Risk difference, group 1 minus group 2 | 0.15 | -0.029 | 0.32 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.05 | 0.849 | 4.94 | log | |
| Odds ratio, group 1 over group 2 | 2.48 | 0.83 | 7.42 | log | |
| Number needed to treat, for one more participant with the outcome on Caffeine Arm than on Placebo Arm | 6.67 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Caffeine Arm | Subjects randomized to this arm will receive blinded Caffeine citrate.~Caffeine citrate: Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation. | 12 | 41 | OG000 |
| Group 2 | Placebo Arm | Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).~Normal saline: Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation. | 6 | 42 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Number of Infants With Severe Intraventricular Hemorrhage
- Description
- Severe intraventricular hemorrhage defined as grade III or higher
- Time frame
- From enrollment until 36 weeks postmenstrual age, discharge or death
- Population
Source ClinicalTrials.gov
Trial
- Title
- Caffeine to Reduce Mechanical Ventilation in Preterm Infants
- NCT number
- NCT01751724
- Phases
- NA
- Conditions
- Prematurity, Apnea, Respiratory Failure
- Interventions
- Caffeine citrate, Normal saline
- Lead sponsor
- University of Miami
- Results first posted
- 2017-06-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01751724?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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