Drug-Related Problems in Neonatal Patients

Hacettepe University

Status: Unknown

Conditions: Adverse Drug Event; Drug-Drug Interaction; Machine Learning; Drug-Related Problems; Neonatal Intensive Care Unit; Clinical Pharmacy; Medication Errors

Treatments: Drug: Clinical Pharmacist Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04899960

KA-20004

Details and patient eligibility

About

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.

Enrollment: 512 estimated patients

Sex: All

Ages: 1 hour to 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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512 participants in 3 patient groups

Observational Group

No Intervention group

Control (Validation) Group

No Intervention group

İnterventional Group

Experimental group

Treatment:

Drug: Clinical Pharmacist Intervention