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A Big Data Approach to Predict NEOnatal Acute Kidney Injury in Newborns expoSed to nephroTOxic Drugs (NeoAKI STOP)

NCT05851222 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 4200

Last updated 2023-05-09

No results posted yet for this study

Summary

This observational retrospective study aims to learn about the incidence of acute kidney (AKI) injury in newborns in infants exposed to nephrotoxic drugs with a big data approach.

The main question it aims to answer are:

* Develop a model that can predict the occurrence of AKI in infants admitted to the NICU;
* Identify the drug or combination of drugs associated with an increased risk of AKI.

The group of infants exposed to drugs will be defined based on exposure for at least 1-day tone one or more therapies commonly used in the NICU. Once the AKI event has occurred, the observation of the trend of daily creatinine and diuresis values will be continued for the period covered by the study.

Conditions

  • Acute Kidney Injury
  • Drug Use
  • Drug Interaction
  • Drug Toxicity
  • Drug-Induced Nephropathy
  • Machine Learning
  • Newborn Morbidity
  • Premature Birth

Sponsors & Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Principal Investigators

  • Giacomo Cavallaro, MD, PhD · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  • Ilaria Amodeo, MD · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2023-09-30
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05851222 on ClinicalTrials.gov