Improving Preterm Kidney Outcomes With Caffeine

NCT07262060 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: 2025-1079Protocol Version 10/9/2025SMPH\PEDIATRICS\NEONATO1R01HD116793-01
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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

Keywords

caffeine; acute kidney injury

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 3 hours post-intervention (Between days 1 and 17)

Secondary Outcomes (2)

• Number of Days of Acute Kidney Injury (AKI)

  14 days after intervention

• Proportion of Participants with a Sustained Decrease in Cerebral Oxygenation

  up to 3 hours post-intervention (Between days 1 and 17)

Other Outcomes (3)

• Change in Urinary Biomarker Concentrations

  baseline, day 17

• Rates of Brain Injury

  up to 6 months

• Rates of Abnormal General Movement Assessment (GMA)

  up to 6 months

Study Arms (3)

Arm 1: Caffeine

EXPERIMENTAL

Drug: Caffeine citrate

Arm 2: Placebo

PLACEBO COMPARATOR

Drug: Placebo

Arm 3: Control

NO INTERVENTION

Interventions

Caffeine citrate DRUG

intravenous (IV) caffeine citrate (20 milligrams per kilogram) (n = 45) followed by 8 milligrams per kilogram daily maintenance

Arm 1: Caffeine

Placebo DRUG

same volume of 0.9 percent Sodium Chloride United States Pharmacopeia (USP) (n=45)

Also known as: saline

Arm 2: Placebo

Eligibility Criteria

• Age: 12 Hours - 96 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of Wisconsin, Madison: lead

Study Sites (1)

UW Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Premature Birth; Acute Kidney Injury

Interventions

caffeine citrate; Sodium Chloride

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Matthew W Harer, MD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Alfaro, CCRP

CONTACT

(608) 890-0584; elalfaro@wisc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, placebo-controlled, double blind, single-center trial of the effectiveness of additional caffeine compared to placebo in preterm neonates less than 30 weeks gestational age.

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: March 25, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)