Recruiting
Phase 2

Caffeine Citrate

Sponsor:

University of Wisconsin, Madison

Code:

NCT07262060

Conditions

Kidney Injury

Pre-Term

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Caffeine citrate

Placebo

Study Details

Brief 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

Study ID

NCT07262060

Start date

May 28, 2026

Status verified date

Mar, 2026

Completion date

Sep, 2030

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • Receiving caffeine at the time of enrollment
  • Have a birth parent who is at least 18 years old and have a parent or guardian who is able to provide parental permission in English or Spanish

Exclusion Criteria:

  • 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.

Study Design

Enrollment

114 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1: Caffeine

placebo comparator: Arm 2: Placebo

no intervention: Arm 3: Control

Interventions

Caffeine citrate

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

Placebo

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

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 and Locations

Central contacts

Elena Alfaro, CCRP

(608) 890-0584elalfaro@wisc.edu

Locations

UW Hospital and Clinics

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Jun 4, 2026

Last verified

Mar, 2026

Keywords

  • caffeine
  • acute kidney injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-06-04.