Improving Preterm Kidney Outcomes With Caffeine

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT07262060
Phase
PHASE2
Status
Recruiting
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Conditions

  • Kidney Injury
  • Pre-Term

Eligibility Criteria

Sex
ALL
Age
12 Hours - 96 Hours
Healthy Volunteers
Not accepted

Interventions

  • Caffeine citrate — DRUG
    intravenous (IV) caffeine citrate (20 milligrams per kilogram) followed by 8 milligrams per kilogram daily maintenance
  • Placebo — DRUG
    same volume of 0.9 percent Sodium Chloride United States Pharmacopeia (USP)

Study Details

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.

Key Dates

Start date
May 28, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2030
Completion
Sep 30, 2030

Study Design

Enrollment
114 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Caffeine
  • Placebo Comparator: Arm 2: Placebo
  • No Intervention: Arm 3: Control

Primary Outcome Measure

Proportion of Participants with Improvement in Kidney Oxygenation [ Time Frame: Up to 3 hours post-intervention (Between days 1 and 17) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UW Hospital and ClinicsMadisonWisconsin53792-

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By research site
UW Hospital and Clinics· Madison, WI

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