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

September 17, 2019 updated by: Adam R Frymoyer, Stanford University
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 Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94305-5208
        • Lucile Packard Children's Hospital Stanford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Neonates with AKI admitted in the NICU who receive aminophylline.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Aminophylline per standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Drug concentrations of theophylline
Time Frame: Day 1 or 2 and Day 3,4, or 5
Day 1 or 2 and Day 3,4, or 5

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

October 21, 2014

First Submitted That Met QC Criteria

October 23, 2014

First Posted (Estimate)

October 28, 2014

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29957

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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