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Pharmacology of Aminophylline for Acute Kidney Injury in Neonates (PAANS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02276170
Recruitment Status : Terminated (insufficient rate of accrual)
First Posted : October 28, 2014
Last Update Posted : September 19, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Adam R Frymoyer, Stanford University

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.

Condition or disease
Acute Kidney Injury

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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : October 2014
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Group/Cohort
Aminophylline per standard of care



Primary Outcome Measures :
  1. Drug concentrations of theophylline [ Time Frame: Day 1 or 2 and Day 3,4, or 5 ]

Secondary Outcome Measures :
  1. Change in renal Near-infrared spectroscopy (NIRS) [ Time Frame: Day 1,2,3,4 ]
  2. Change in urine output [ Time Frame: Day 1,2,3,4 ]
  3. Number of participants with adverse events [ Time Frame: 5 days ]
  4. Change in urine biomarker levels [ Time Frame: Day 1,2,3,4,5 ]
  5. Change in serum creatinine level [ Time Frame: Day 1,2,3,4,5 ]


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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neonates with AKI admitted in the NICU who receive aminophylline.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276170


Locations
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United States, California
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States, 94305-5208
Sponsors and Collaborators
Stanford University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Adam Frymoyer, MD Stanford University
Publications:

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Responsible Party: Adam R Frymoyer, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02276170    
Other Study ID Numbers: 29957
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases