Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm

Phase 3 Completed 98 enrolled American SIDS Institute

RandomizedParallel-groupOpen-labelTreatment

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%.

Timeline

Start: 2010-07
Primary completion: 2011-12
Completion: 2011-12

Publications

Results Rhein LM, Dobson NR, Darnall RA, Corwin MJ, Heeren TC, Poets CF, McEntire BL, Hunt CE; Caffeine Pilot Study Group. Effects of caffeine on intermittent hypoxia in infants born prematurely: a randomized clinical trial. JAMA Pediatr. 2014 Mar;168(3):250-7. doi: 10.1001/jamapediatrics.2013.4371.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Caffeine	Small molecule	6 mg/kg	Oral

Indications

No indication recorded.