Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study of Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm|
- Episodes and seconds/hour of intermittent hypoxia [ Time Frame: Baseline and 40 weeks postmenstrual age ] [ Designated as safety issue: No ]Intermittent hypoxia: number of episodes per hour of pulse oximeter recording of oxygen saturation to less than 90%, and sec/hour of recording to less than 90%.
|Study Start Date:||July 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Caffeine citrate 6 mg/kg/day
Drug: Caffeine citrate 6 mg/kg/day
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.
Other Name: Cafcit
No Intervention: Active Comparator: no caffeine
Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
Infants with prior clinical treatment with caffeine in the neonatal intensive care unit (NICU) will be enrolled and continuous physiologic data recording of oxygen hemoglobin saturation (HbO2 SAT) and heart rate will begin as early as 33 weeks postmenstrual age (PMA). Randomization will occur when enrolled infants reach a corrected gestational age of at least 34 weeks PMA AND clinical caffeine has been discontinued for at least 5 days. Infants will be randomized to receive caffeine or to continue with usual care. The group randomized to start caffeine will receive an oral loading dose of caffeine citrate of 20 mg/kg on Day #1, followed by a single daily oral maintenance dose of 6 mg/kg starting on Day #2 and continued daily thereafter until 40 weeks PMA. The continuous oximeter recordings will be stopped at the same time. The number of intermittent hypoxia events/hour per week and the frequency/duration of bradycardia will be compared between the caffeine group and the usual care (no-caffeine) group for each week of physiologic data recordings.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01875159
|United States, Maryland|
|Uniformed Services University of Health Sciences|
|Bethesda, Maryland, United States, 20814|
|Study Director:||Betty McEntire, PhD||American SIDS Instittute|