Drug-Related Problems in Neonatal Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Machine Learning; Adverse Drug Event; Drug-Drug Interaction; Neonatal Intensive Care Unit; Medication Errors; Drug-Related Problems; Clinical Pharmacy
• Intervention / Treatment: Drug: Clinical Pharmacist Intervention

• Study Type: Interventional
• Enrollment (Anticipated): 512
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nadir Yalçın, MSc; Phone Number: +905356849300; Email: nadir.yalcin@hotmail.com

Study Locations

• Turkey
  • TR
    • Ankara, TR, Turkey, 06100
      • Recruiting
      • Nadir Yalçın
      • Contact: Nadir Yalçın, MSc; Phone Number: +903123052043; Email: nadir.yalcin@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Observational Group
No Intervention: Control (Validation) Group
Experimental: İnterventional Group	Drug: Clinical Pharmacist Intervention; Prevention of drug-related problems by clinical pharmacist in neonatal intensive care unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score for Neonatal Acute Physiology and Perinatal Extension Score	Score for Neonatal Acute Physiology and Perinatal Extension Score is predictor of mortality in neonates.	Through study completion, an average of 1 year.
Neonatal Therapeutic Intervention Scoring System	It is a therapy-based severity of illness (morbidity) assessment index.	Through study completion, an average of 1 year.
Neonatal Early-Onset Sepsis Risk Score	It is use first week of life for determined sepsis risk with gestational age, highest maternal antepartum temperature, duration of rupture of membranes, etc.	Through study completion, an average of 1 year.
Neonatal Nutrition Screening Tool	It could be used on all infants in the neonatal intensive care on a weekly basis by nursing staff to identify those at high risk of poor growth and in need of additional nutrition support during their stay.	Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal Adverse Event Severity Scale	It describes a consensus process that led to the development of standard severity criteria for neonatal adverse events. The use of this tool could improve the quality of drug and device safety evaluations and facilitate the conduct of neonatal clinical trials.	Through study completion, an average of 1 year.
The Drug Interaction Probability Scale	This scale uses a series of questions relating to the potential drug interaction to estimate a probability score.	Through study completion, an average of 1 year.
Adverse Drug Reactions Algorithm for Infants	The new algorithm developed using actual patient data is more valid and reliable than the Naranjo algorithm for identifying adverse drug reactions in the neonatal intensive care unit population.	Through study completion, an average of 1 year.
National Aeronautics and Space Administration Task Load Index	NASA Task Load Index (NASA-TLX) is a widely used, subjective, multidimensional assessment tool that rates perceived workload in order to assess a task, system, or team's effectiveness or other aspects of performance.	Through study completion, an average of 1 year.

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: Nadir Yalçın, MSc, Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: KA-20004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No