Improving Preterm Kidney Outcomes With Caffeine

NCT ID: NCT07262060

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2030-09-30

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.

Detailed Description

The study population will consist of 102 preterm neonates born less than 30 weeks gestational age who have an intravenous (IV) line for which IV medications can be administered and who can have brain and kidney Near Infrared Spectroscopy (NIRS) monitoring.

Eligible participants will be enrolled between 12-96 hours of life after preterm birth and admission to the Meriter NICU. Baseline data will be collected and NIRS monitoring will be started when appropriate as determined by the team based on clinical guidelines and standard of care.

Those participants having kidney oxygenation less than 50 percent (and troubleshooting procedures have occurred and while ensuring brain oxygenation is not below 55 percent) after 48 hours and within the first 14 DOL will be randomized in a 1:1 manner to one of two treatment arms (Arm 1 and Arm 2).

• Arm 1: IV caffeine citrate (20 mg/kg) (n = 45)
• Arm 2: Placebo - same volume of 0.9% Sodium Chloride United States Pharmacopeia (USP) (n=45)

Those participants who do not develop kidney hypoxia during the first 14 DOL will be the normal kidney oxygenation control group and receive no intervention (Arm 3).

• Arm 3: Normal Kidney oxygenation (no intervention) (Approximately n = 12)

Participant accrual will occur over 48 months. Participants will complete all study specific activities during the NICU hospitalization over the course of the first 28 DOL and clinical outcomes will be collected through NICU discharge or 6 months of age, whichever occurs first. Each participant will contribute blood specimens for creatinine and caffeine levels as well as approximately 20-40 urine samples for biomarker analysis.

Conditions

Kidney Injury; Pre-Term

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1: Caffeine

Group Type: EXPERIMENTAL

Caffeine citrate

Intervention Type: DRUG

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

Arm 2: Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Arm 3: Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Caffeine citrate

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

saline

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Hours
• Maximum Eligible Age: 96 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew W Harer, MD

Role: PRINCIPAL_INVESTIGATOR

UW School of Medicine and Public Health

Locations

UW Hospital and Clinics

Madison, Wisconsin, United States

Countries

United States

Central Contacts

Elena Alfaro, CCRP

Role: CONTACT

elalfaro@wisc.edu

(608) 890-0584

Other Identifiers

Protocol Version 10/9/2025

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\PEDIATRICS\NEONATO

Identifier Type: OTHER

Identifier Source: secondary_id

1R01HD116793-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2025-1079

Identifier Type: -

Identifier Source: org_study_id