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New treatment option for Kidney Injury
Official title Improving Preterm Kidney Outcomes With Caffeine
ClinicalTrials.gov ID: NCT07262060
What this study is testing
What is Caffeine citrate?
Caffeine citrate is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for kidney injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 48 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 96
You may be able to join 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...
- Receiving caffeine at the time of enrollment
You likely can't join 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Madison, Wisconsin, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 48 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 hours to 96 hours. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madison, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.