Improving Preterm Kidney Outcomes With Caffeine
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-96
SponsorUniversity of Wisconsin, Madison
About this trial
This study is being done to see if additional caffeine citrate (20 milligrams per kilogram IV bolus) helps babies with low kidney oxygenation already being treated with caffeine citrate (20 milligrams per kilogram IV bolus on day of life (DOL) 1 followed by 8 milligrams per kilogram daily maintenance). The investigators hypothesize that additional caffeine will improve kidney oxygen levels, while not causing any brain injury, and may reduce rates of acute kidney injury compared to placebo. This study will take place in preterm babies born less than 30 weeks gestational age, with the intervention occurring between greater than 48 hours of age until DOL 14 and outcomes tracked until neonatal intensive care unit (NICU) discharge.
Eligibility criteria
Qualifiers
Gestational age at birth between 23 0/7 and 29 6/7 weeks.
Able to have near-infrared spectroscopy (NIRS) monitoring of cerebral and kidney oxygenation.
Able to receive IV medications.
Indwelling umbilical arterial catheter (UAC), umbilical venous catheter (UVC), peripheral arterial line (PAL), or peripherally inserted central catheter (PICC) already in place that can draw blood.
Disqualifiers
Known or suspected major congenital anomaly of the brain, heart, lungs or kidney (excluding UTD A1 pyelectasis).
Known or suspected chromosomal or genetic anomaly.
Not suitable for study participation due to other reasons at the discretion of the investigators.
Trial design
Treatments tested in this trial
- Caffeine citrate
- Placebo
Treatment groups
114 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Wisconsin, Madison
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov