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Improving Preterm Kidney Outcomes With Caffeine

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description expanded, about 3 words
  2. Start date changed from estimate of Jun 2026 to May 28, 2026v6
  3. Recruitment opened
    • Start date: May 2026 to Jun 2026
    v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v4
  5. Enrollment increased: 102 → 114 participants
    • Start date: Apr 2026 to May 2026
    • Study description revised
    v3
  6. Start date: Mar 2026 to Apr 2026v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07262060
Lead Sponsor University of Wisconsin, Madison
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)		 Kidney Injury, Pre-Term
Related terms Acute Kidney Injury, Premature Birth
Enrollment 114 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov