Drug-Related Problems in Neonatal Patients

Adverse Drug Event Clinical Trial

Official title:

Drug-Related Problems in Neonatal Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04899960
• Other study ID #: KA-20004
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: November 1, 2021

Study information

• Verified date: May 2021
• Source: Hacettepe University
• Contact: Nadir Yalçin, MSc
• Phone: +905356849300
• Email: nadir.yalcin[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 512
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Adverse Drug Event
• Clinical Pharmacy
• Drug-Drug Interaction
• Drug-Related Problems
• Drug-Related Side Effects and Adverse Reactions
• Machine Learning
• Medication Errors
• Neonatal Intensive Care Unit

Intervention

Drug:
• Clinical Pharmacist Intervention
Prevention of drug-related problems by clinical pharmacist in neonatal intensive care unit.

Locations

Country	Name	City	State
Turkey	Nadir Yalçin	Ankara	TR

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Neonatal Therapeutic Intervention Scoring System	It is a therapy-based severity of illness (morbidity) assessment index.	Through study completion, an average of 1 year.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.