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Comparison · NCT03913221-ef18a90d

Low Dose Caffeine (5 mg/kg) vs High Dose Caffeine (10 mg/kg): Number of Participants With Seizures Requiring >1 Anti-Epileptic Medication

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. Low Dose Caffeine (5 mg/kg) vs High Dose Caffeine (10 mg/kg): Number of Participants With Seizures Requiring >1 Anti-Epileptic Medication. Trial comparisons, record NCT03913221-ef18a90d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03913221-ef18a90d

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.1110.01990.435wilson
Risk in group 2000.324wilson
Risk difference, group 1 minus group 20.111-0.2260.435newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treat, for one more participant with the outcome on Low Dose Caffeine (5 mg/kg) than on High Dose Caffeine (10 mg/kg)9from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Low Dose Caffeine (5 mg/kg)
Within 24 hours of delivery, participants will receive low dose administration of Caffeine citrate.~Caffeine Citrate 5 mg/kg: Loading dose of caffeine 20 mg/kg IV followed by two daily doses of 5 mg/kg IV.
19OG000
Group 2High Dose Caffeine (10 mg/kg)
Within 24 hours of delivery, participants will receive high dose administration of Caffeine citrate.~Caffeine Citrate 10 mg/kg: Loading dose of caffeine 20 mg/kg IV followed by two daily doses of 10 mg/kg IV.
08OG001

Outcome

Type
SECONDARY
Title
Number of Participants With Seizures Requiring >1 Anti-Epileptic Medication
Description
As a potential complication of caffeine exposure, seizure activity requiring \>1 anti-epileptic medication is reported.
Time frame
From the first dose of caffeine to 7 days following the final dose.
Population

Source ClinicalTrials.gov

Trial

Title
Caffeine for Hypoxic-Ischemic Encephalopathy
NCT number
NCT03913221
Phases
PHASE1
Conditions
Hypoxic-Ischemic Encephalopathy
Interventions
Caffeine Citrate 5 mg/kg, Caffeine Citrate 10 mg/kg
Lead sponsor
University of North Carolina, Chapel Hill
Results first posted
2024-09-19

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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