A Phase 2 interventional study of Caffeine citrate and Placebo in Kidney Injury and Pre-Term, sponsored by University of Wisconsin, Madison. Recruiting at 1 site in United States. Open to participants aged 12 Hours to 96 Hours. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by University of Wisconsin, Madison · Phase 2, Interventional, and Treatment
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.
The study population will consist of 114 preterm neonates born less than 30 weeks gestational age who have an intravenous (IV) line for which IV medications can be administered and who can have brain and kidney Near Infrared Spectroscopy (NIRS) monitoring.
Eligible participants will be enrolled between 12-96 hours of life after preterm birth and admission to the Meriter NICU. Baseline data will be collected and NIRS monitoring will be started when appropriate as determined by the team based on clinical guidelines and standard of care.
Those participants having kidney oxygenation less than 50 percent (and troubleshooting procedures have occurred and while ensuring brain oxygenation is not below 55 percent) after 48 hours and within the first 14 DOL will be randomized in a 1:1 manner to one of two treatment arms (Arm 1 and Arm 2).
Those participants who do not develop kidney hypoxia during the first 14 DOL will be the normal kidney oxygenation control group and receive no intervention (Arm 3).
Participant accrual will occur over 48 months. Participants will complete all study specific activities during the NICU hospitalization over the course of the first 28 DOL and clinical outcomes will be collected through NICU discharge or 6 months of age, whichever occurs first. Each participant will contribute blood specimens for creatinine and caffeine levels as well as approximately 20-40 urine samples for biomarker analysis.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 114 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
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Exclusion Criteria:
Drug: Caffeine citrate
Drug: Placebo
intravenous (IV) caffeine citrate (20 milligrams per kilogram) followed by 8 milligrams per kilogram daily maintenance
same volume of 0.9 percent Sodium Chloride United States Pharmacopeia (USP)
Also known as: saline
Proportion of Participants with Improvement in Kidney Oxygenation
In the 3 hours after receiving the intervention or placebo, participants have kidney oxygenation monitored. Improvement in oxygenation is defined as having 30 minutes where at least 90 percent of measured values are at least 50 percent.
Time frame: Up to 3 hours post-intervention (Between days 1 and 17)
Number of Days of Acute Kidney Injury (AKI)
AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) foundation. Outcome is measured for the 14 days after intervention.
Time frame: 14 days after intervention
Proportion of Participants with a Sustained Decrease in Cerebral Oxygenation
In the 3 hours after receiving the intervention or placebo, participants have cerebral oxygenation monitored. A sustained decrease in cerebral oxygenation is defined as less than 60 percent oxygenation for at least 60 minutes.
Time frame: up to 3 hours post-intervention (Between days 1 and 17)
Change in Urinary Biomarker Concentrations
Time frame: baseline, day 17
Rates of Brain Injury
Rates of Brain injury (Periventricular Leukomalacia (PVL) or Interventricular hemorrhage (IVH) on term corrected brain imaging prior to discharge in participants receiving additional caffeine compared to those receiving placebo.
Time frame: up to 6 months
Rates of Abnormal General Movement Assessment (GMA)
Rates of abnormal GMA prior to discharge in participants receiving additional caffeine compared to those receiving placebo.
Time frame: up to 6 months
Plan to share: Yes — This study will submit data to the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH). NICHD DASH is a NICHD-funded controlled access data repository established to facilitate data sharing and access to biospecimens for all NICHD clinical research. This study will produce four data types: Clinical data, Urine proteomic biomarker, PK/PD data, and near infrared spectroscopy (NIRS) oxygenation data. The final clinical dataset will include demographic data and study-related tests obtained from the electronic medical record. The urine proteomic data will contain output from the biological urine samples from each research subject. The PK/PD data will contain caffeine serum concentration and renal oxygenation data at various timepoints, dose levels, and selected demographic and clinical data. The NIRS oxygenation dataset will include every 1 second kidney and cerebral oxygenation percentage generated/obtained from INVOS Medtronic NIRS 7100 devices.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Caffeine citrate
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