Improving Preterm Kidney Outcomes With Caffeine

ConditionsKidney Injury Pre-Term

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age12-96

SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

Caffeine citrate
Drug
intravenous (IV) caffeine citrate (20 milligrams per kilogram) followed by 8 milligrams per kilogram daily maintenance
Placebo
Drug
same volume of 0.9 percent Sodium Chloride United States Pharmacopeia (USP)

Treatment groups

114 Participants

are divided into 3 treatment groups

Group A: Arm 1: CaffeineExperimental treatment 1 intervention

Group B: Arm 2: PlaceboPlacebo comparator 1 intervention

Group C: Arm 3: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame

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

Secondary outcomes

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.

Time frame

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.

Time frame

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

Other outcomes

Change in Urinary Biomarker Concentrations

Time frame

baseline, day 17

Rates of Brain Injury

Rates of Brain injury (Periventricular Leukomalacia (PVL) or Interventricular hemorrhage (IVH) on term corrected brain imaging prior to discharge in participants receiving additional caffeine compared to those receiving placebo.

Time frame

up to 6 months

Rates of Abnormal General Movement Assessment (GMA)

Rates of abnormal GMA prior to discharge in participants receiving additional caffeine compared to those receiving placebo.

Time frame

up to 6 months