Clinical trial NCT04899960: Drug-Related Problems in Neonatal Patients
Official title: Drug-Related Problems in Neonatal Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neonatal Intensive Care Unit
Medication Errors
Drug-Related Problems
Adverse Drug Event
Drug-Drug Interaction
Clinical Pharmacy
Machine Learning
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 512
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Drug-related problems in newborn babies have been reported with a rate of 4-30%. It is estimated that the higher rates of these problems in hospitalized children under the age of two are related to the variety of drugs used and the differences in the age, weight and diagnosis of the patients. In this context, with the clinical parameters and demographic data obtained in the first 24 hours of the patients hospitalized in the neonatal intensive care unit, machine learning algorithms are used to predict the risks that may arise from possible drug-related problems (prescribing and administration errors, side effects and drug-drug interactions) that may occur during hospitalization. The algorithm, which will be created by modeling with a high number of big data pool, is planned to be transformed into a clinical decision support system software that can be used easily in clinical practice with online and mobile applications. By processing the data of the patients to be included in the model, it is aimed to prevent and manage drug-related problems before they occur, as well as to provide cost-effective medşcation treatment to patients hospitalized in the neonatal intensive care unit, together with a reduction in the risk of drug-related mortality and morbidity.


Eligibility criteria: Inclusion Criteria:

* Newborns aged 0-28 days,
* Consent form taken by the parents to participate in the study,
* Patients admitted to neonatal intensive care unit or surgical wards

Exclusion Criteria:

* Have a postnatal age greater than 28 days,
* Patients who will not be given any medication,
* Patients who took part in any drug research within the last 28 days

Primary outcomes:
measure: Score for Neonatal Acute Physiology and Perinatal Extension Score
timeFrame: Through study completion, an average of 1 year.
measure: Neonatal Therapeutic Intervention Scoring System
timeFrame: Through study completion, an average of 1 year.
measure: Neonatal Early-Onset Sepsis Risk Score
timeFrame: Through study completion, an average of 1 year.
measure: Neonatal Nutrition Screening Tool
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Neonatal Adverse Event Severity Scale
timeFrame: Through study completion, an average of 1 year.
measure: The Drug Interaction Probability Scale
timeFrame: Through study completion, an average of 1 year.
measure: Adverse Drug Reactions Algorithm for Infants
timeFrame: Through study completion, an average of 1 year.
measure: National Aeronautics and Space Administration Task Load Index
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Nadir Yalçın
state: TR
Study officials:
affiliation: Hacettepe University
name: Nadir Yalçın, MSc
role: PRINCIPAL_INVESTIGATOR
References: