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

NCT05851222 | Unknown

• 1 other identifier: NeoAKI STOP
• Study Type: observational
• Target: 4,200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Develop a model that can predict the occurrence of AKI in infants admitted to the NICU;

  All available serum creatinine values for each patient during the NICU admission will be recorded, considering that determinations made within the first 48 hours of the infant's life are affected by maternal creatinine values. The presence of AKI will be determined according to the modified KIDGO criteria for the newborn, as reported in previous work in the neonatal setting (Jetton JG, 2017; Jetton JG and Askenazi DJ, 2012; Stoops C, 2016; Askenazi DJ, Patil NR, et al., 2015; Sarkar S, 2014).

  From the date of randomization until the date of the first documented progression of AKI and up to 4 weeks

• 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. Special attention will be given to exposure to antibiotics, antivirals, antifungals, diuretics, anti-inflammatories, inotropes, and vasopressors. In addition to the active ingredient, other significant data such as prescribed dose, administration route, treatment duration, and temporal relationship between treatment and diagnosis of AKI will also be considered.

  From the date of randomization until the date of the first documented progression of AKI and up to 4 weeks

Secondary Outcomes (2)

• Identify subgroups of patients at increased risk of AKI

  From the date of randomization until the date of the first documented progression of AKI and up to 4 weeks

• Identify time windows at increased risk of AKI during NICU admission.

  From the date of randomization until the date of the first documented progression of AKI and up to 4 weeks

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients admitted to NICU and born between January 2010 and December 2022

You may qualify if:

• born between 01/01/2010 and 31/12/2022;
• admitted within 24 hours of birth in the NICU (both inborn and outborn);
• availability of at least two serum creatinine values or a daily hourly diuresis assessment in the first 30 days of life.

You may not qualify if:

• pre- or postnatal diagnosis of severe urologic and/or nephrologic pathology on a malformative and/or genetic basis;
• finding of serum creatinine \> 2 mg/dl in the first 24 hours of life;
• genetic conditions that may impact patient survival or renal function;
• length of stay in the NICU less than 48 hours (death or transfer to another department);
• infants undergoing ECMO.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, MI, 20129, Italy

Location

Related Publications (44)

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MeSH Terms

Conditions

Acute Kidney Injury; Drug-Related Side Effects and Adverse Reactions; Premature Birth

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chemically-Induced Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications

Study Officials

• Giacomo Cavallaro, MD, PhD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  STUDY DIRECTOR

• Ilaria Amodeo, MD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giacomo Cavallaro, MD, PhD

CONTACT

+390255032234; giacomo.cavallaro@policlinico.mi.it

Ilaria Amodeo, MD

CONTACT

+390255032234; amodeoilaria@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2023
• First Posted: May 9, 2023
• Study Start: August 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2024
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)