Intermittent Hypoxia and Caffeine in Infants Born Preterm
Status:
Recruiting
Trial end date:
2022-05-01
Target enrollment:
Participant gender:
Summary
Intermittent Hypoxia and Caffeine in Infants Born Preterm (ICAF) Our proposal will address
the critical question: is persisting intermittent hypoxia (IH) in preterm infants associated
with biochemical, structural, or functional injury, and is this injury attenuated with
extended caffeine treatment? The investigators will study the effects of caffeine on IH in
220 preterm infants born at ≤30 weeks + 6 days gestation. Infants who are currently being
treated with routine caffeine, and who meet eligibility criteria, will be enrolled between 32
weeks + 0 days and 36 weeks + 6 days PMA. At enrollment, infants will be started on
continuous pulse oximeter recording of O2 saturation and heart rate. If, based on standard
clinical criteria, the last dose of routine caffeine is given on or before the day the infant
is 36 weeks + 5 days PMA, then on the day following their last dose of routine caffeine
treatment, infants will be randomized (110/group) to extended caffeine treatment or placebo.
Randomized infants should begin receiving study drug (i.e. 5 mg/kg/of caffeine base, or equal
volume of placebo) on the day of randomization, but no later than the third calendar day
following the last dose of routine caffeine. Prior to 36 weeks + 0 days PMA, study drug will
be given once daily (i.e. 5mg/kg/day) and beginning at 36 weeks + 0 days PMA, study drug will
be given twice daily (i.e. 10 mg/kg/day). The last dose of study drug will be given at 42
weeks + 6 days PMA. Pulse oximeter recordings will continue 1 additional week after
discontinuing study drug. Two caffeine levels will be obtained, the 1st at one week after
beginning study drug, and the 2nd at a target date of 40 weeks + 0 days PMA, but no later
than the last day of study drug, whether in hospital or at home. Inflammatory biomarkers will
be measured at study enrollment and again at 38 weeks + 0 days PMA, or within 2 calendar days
prior to hospital discharge, whichever comes first. Quantitative MRI/MRS should be obtained
between study enrollment and 3 calendar days after starting study drug and again at a target
date of 43 weeks + 0 days, but no later than 46 weeks + 6 days PMA.
Phase:
Phase 2
Details
Lead Sponsor:
Children's National Research Institute Children's Research Institute
Collaborators:
American SIDS Institute Beth Israel Medical Center Boston University Children's Hospital of Philadelphia Dartmouth-Hitchcock Medical Center Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Johns Hopkins All Children's Hospital University of Massachusetts, Worcester Walter Reed National Military Medical Center Washington Hospital Center