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Trial · NCT05295784

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryClearance of caffeine1 weekClearance (mL h-1 kg-1)
PrimaryVolume of distribution of caffeine1 weekVolume of distribution (ml/kg)
PrimaryPeak plasma concentration (Cmax) of caffeine1 weekPeak plasma concentration (Cmax) (ng/mL)
PrimaryArea under the plasma concentration-time curve of caffeine1 weekArea under the plasma concentration-time curve from 0 to infinity (AUC0-INF) (mg\*h/L)
PrimarySeizure incidence2 weeksNumber of neonates who developed seizures based on continuous video electroencephalogram (VEEG) data
PrimarySeizure burden2 weeksElectrographic seizures (in minutes per hour) based on continuous video electroencephalogram (VEEG) data
SecondaryAcute kidney injury10 daysAKI incidence utilizing KDIGO criteria based on urine output and SCr.
SecondaryRenal near infrared spectroscopy (NIRS)5 daysInvestigate changes in renal NIRS values during the therapeutic hypothermia and rewarming period.
SecondaryUrine neutrophil gelatinase-associated lipocalin (NGAL) (ng/mL)3 daysUrine samples will be collected at 24, 48 and 72 hours after birth. Urine will be analyzed for NGAL.
SecondaryUrine kidney injury molecule-1 (KIM-1) (pg/mL)3 daysUrine samples will be collected at 24, 48 and 72 hours after birth. Urine will be analyzed for KIM-1.
SecondaryUrine interleukin-18 (IL-18) (pg/mL)3 daysUrine samples will be collected at 24, 48 and 72 hours after birth. Urine will be analyzed for IL-18.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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