Clinical trial NCT02276170: Pharmacology of Aminophylline for Acute Kidney Injury in Neonates
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Kidney Injury
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-10-28
Enrollment: 9
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates with AKI admitted in the NICU who receive aminophylline.

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Drug concentrations of theophylline
timeFrame: Day 1 or 2 and Day 3,4, or 5
Secondary outcomes:
measure: Change in renal Near-infrared spectroscopy (NIRS)
timeFrame: Day 1,2,3,4
measure: Change in urine output
timeFrame: Day 1,2,3,4
measure: Number of participants with adverse events
timeFrame: 5 days
measure: Change in urine biomarker levels
timeFrame: Day 1,2,3,4,5
measure: Change in serum creatinine level
timeFrame: Day 1,2,3,4,5
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
Study officials:
affiliation: Stanford University
name: Adam Frymoyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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