At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 98 enrolled
Drug / intervention
Caffeine citrate 6 mg/kg/daydrug
Likely dose
Caffeine citrate 6 mg/kg/dayfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pilot Study of Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm
In Brief
A Phase 3 clinical trial evaluating Caffeine citrate 6 mg/kg/day for Hypoxia. Completed, enrolled 98 participants across 1 site.
Detailed Summary
The purpose of this pilot study is to document the extent to which intermittent hypoxia persists beyond the age of discontinuing clinical methylxanthine, and will assess the effect of caffeine treatment on the number of intermittent hypoxia episodes and the total number of seconds with a hemoglobin oxygen saturation (HbO2 SAT) below 90%.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypoxia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2010
Primary CompletionDec 2011
First PostedJun 2013
TodayJul 2026
First PostedJun 11, 2013
Enrollment StartJul 1, 2010
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.1 years ago
Interventions
Caffeine citrate 6 mg/kg/daydrug
Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age.