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Improving Preterm Kidney Outcomes With Caffeine

NCT07262060 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2026-04-03

No results posted yet for this study

Summary

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.

Conditions

  • Kidney Injury
  • Pre-Term

Interventions

DRUG

Caffeine citrate

intravenous (IV) caffeine citrate (20 milligrams per kilogram) followed by 8 milligrams per kilogram daily maintenance

DRUG

Placebo

same volume of 0.9 percent Sodium Chloride United States Pharmacopeia (USP)

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Matthew W Harer, MD · UW School of Medicine and Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Hours
Max Age
96 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2030-03-31
Completion
2030-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07262060 on ClinicalTrials.gov