Kidney InjuryPhase 2NCT07262060
Improving Preterm Kidney Outcomes With Caffeine
A Phase 2 study testing Caffeine citrate in people with Kidney Injury and Pre-Term, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 96 hours
- Conditions the study is for
- Kidney Injury, Pre-Term
- What is being tested?
- Caffeine citrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2026to Sep 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 96 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UW Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: Optimizing Caffeine Therapy for Hypoxia in Preterm Neonates: A Randomized Trial Assessing Efficacy, Acute Kidney and Brain Injury, Safety, and Pharmacokinetics
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.
Read the detailed description
The study population will consist of 114 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 = 51)
- Arm 2: Placebo - same volume of 0.9% Sodium Chloride United States Pharmacopeia (USP) (n=51)
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
- Being tested
- Caffeine citrate, Placebo
- Keywords
- caffeine, acute kidney injury
- Medical subject headings
- Premature Birth, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine citrateDrug
intravenous (IV) caffeine citrate (20 milligrams per kilogram) followed by 8 milligrams per kilogram daily maintenance
PlaceboDrug
Also called saline
same volume of 0.9 percent Sodium Chloride United States Pharmacopeia (USP)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Caffeine | Experimental | Not described Receives: Drug: Caffeine citrate |
| Arm 2: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Arm 3: Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 hours post-intervention (Between days 1 and 17)
Secondary outcomes (2)
Number of Days of Acute Kidney Injury (AKI)
AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) foundation. Outcome is measured for the 14 days after intervention.
Measured: 14 days after intervention
Proportion of Participants with a Sustained Decrease in Cerebral Oxygenation
In the 3 hours after receiving the intervention or placebo, participants have cerebral oxygenation monitored. A sustained decrease in cerebral oxygenation is defined as less than 60 percent oxygenation for at least 60 minutes.
Measured: up to 3 hours post-intervention (Between days 1 and 17)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start28 May 2026
- Primary completionMar 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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. Multiples will be randomized to the same arm of the study, the first born will be randomized to determine arm.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Matthew W Harer, MD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262060
- Sponsor's protocol ID
- 2025-1079
- Other IDs
- 1R01HD116793-01, Protocol Version 5/22/2026, SMPH\PEDIATRICS\NEONATO
- Status last verified
- Sep 2026
- First submitted
- 21 Nov 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will submit data to the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH). NICHD DASH is a NICHD-funded controlled access data repository established to facilitate data sharing and access to biospecimens for all NICHD clinical research. This study will produce four data types: Clinical data, Urine proteomic biomarker, PK/PD data, and near infrared spectroscopy (NIRS) oxygenation data. The final clinical dataset will include demographic data and study-related tests obtained from the electronic medical record. The urine proteomic data will contain output from the biological urine samples from each research subject. The PK/PD data will contain caffeine serum concentration and renal oxygenation data at various timepoints, dose levels, and selected demographic and clinical data. The NIRS oxygenation dataset will include every 1 second kidney and cerebral oxygenation percentage generated/obtained from INVOS Medtronic NIRS 7100 devices.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Caffeine Therapy for Hypoxia in Preterm Neonates: A Randomized Trial Assessing Efficacy, Acute Kidney and Brain Injury, Safety, and Pharmacokinetics
- ClinicalTrials.gov ID
- NCT07262060
- Acronym / sponsor ID
- 2025-1079
- Conditions
- Kidney Injury, Pre-Term
- Keywords
- caffeine, acute kidney injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 28 May 2026 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 114 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 = 51)
- Arm 2: Placebo - same volume of 0.9% Sodium Chloride United States Pharmacopeia (USP) (n=51)
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 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. Multiples will be randomized to the same arm of the study, the first born will be randomized to determine arm.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Caffeine | Experimental | Drug: Caffeine citrate |
| Arm 2: Placebo | Placebo comparator | Drug: Placebo |
| Arm 3: Control | No intervention | – |
Who may qualify
- Ages
- 12 to 96 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine citrateintravenous (IV) caffeine citrate (20 milligrams per kilogram) followed by 8 milligrams per kilogram daily maintenance | Drug | Arm 1: Caffeine |
| PlaceboAlso: salinesame volume of 0.9 percent Sodium Chloride United States Pharmacopeia (USP) | Drug | Arm 2: Placebo |
Primary outcome
Proportion of Participants with Improvement in Kidney Oxygenation
Time frame: Up to 3 hours post-intervention (Between days 1 and 17)
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.
2 secondary outcomes
Number of Days of Acute Kidney Injury (AKI)
Time frame: 14 days after intervention
Proportion of Participants with a Sustained Decrease in Cerebral Oxygenation
Time frame: up to 3 hours post-intervention (Between days 1 and 17)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Yes. This study will submit data to the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH). NICHD DASH is a NICHD-funded controlled access data repository established to facilitate data sharing and access to biospecimens for all NICHD clinical research. This study will produce four data types: Clinical data, Urine proteomic biomarker, PK/PD data, and near infrared spectroscopy (NIRS) oxygenation data. The final clinical dataset will include demographic data and study-related tests obtained from the electronic medical record. The urine proteomic data will contain output from the biological urine samples from each research subject. The PK/PD data will contain caffeine serum concentration and renal oxygenation data at various timepoints, dose levels, and selected demographic and clinical data. The NIRS oxygenation dataset will include every 1 second kidney and cerebral oxygenation percentage generated/obtained from INVOS Medtronic NIRS 7100 devices.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew W Harer, MD principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Caffeine citrate in people with Kidney Injury and Pre-Term, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena Alfaro, CCRP ((608) 890-0584, elalfaro@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with Improvement in Kidney Oxygenation (time frame: Up to 3 hours post-intervention (Between days 1 and 17)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.