Pharmacology of Aminophylline for Acute Kidney Injury in Neonates

Stanford University9 enrolled

Overview

Acute kidney injury (AKI) in critically ill neonates is common and associated with significant morbidity and mortality. No targeted therapeutic treatment strategies have been established for AKI in neonates. Within a clinical pharmacokinetic and pharmacodynamic conceptual framework, this project will examine the medication aminophylline as a potential treatment approach for AKI.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Acute Kidney Injury

Eligibility

Sex: ALLMax age: 3 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Neonate \< 3 months post natal age * Diagnosed with acute kidney injury (AKI) * Receiving aminophylline for AKI treatment as per local standard of care. Exclusion Criteria: * Presence of anatomical renal anomaly based on postnatal evaluation of the patient (hydronephrosis, multicystic kidney, renal agenesis, renal dysplasia, polycystic kidney, or obstructive uropathy) * Patient on renal replacement therapy * Major genetic abnormalities (trisomy 13, 18 or 21).

Locations (1)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, United States

Outcomes

Primary Outcomes

Drug concentrations of theophylline

Time frame: Day 1 or 2 and Day 3,4, or 5

Secondary Outcomes

Change in renal Near-infrared spectroscopy (NIRS)

Time frame: Day 1,2,3,4

Change in urine output

Time frame: Day 1,2,3,4

Number of participants with adverse events

Time frame: 5 days

Change in urine biomarker levels

Time frame: Day 1,2,3,4,5

Change in serum creatinine level

Time frame: Day 1,2,3,4,5

Data from ClinicalTrials.gov

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