Drug-Related Problems in Neonatal Patients

NCT04899960 | Unknown

• 1 other identifier: KA-20004
• Study Type: interventional
• Target: 512
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Neonatal Adverse Event Severity Scale

  Through study completion, an average of 1 year.

• The Drug Interaction Probability Scale

  Through study completion, an average of 1 year.

• Adverse Drug Reactions Algorithm for Infants

  Through study completion, an average of 1 year.

• National Aeronautics and Space Administration Task Load Index

  Through study completion, an average of 1 year.

Study Arms (3)

Observational Group

NO INTERVENTION

Control (Validation) Group

NO INTERVENTION

İnterventional Group

EXPERIMENTAL

Drug: Clinical Pharmacist Intervention

Interventions

Clinical Pharmacist Intervention DRUG

Prevention of drug-related problems by clinical pharmacist in neonatal intensive care unit.

İnterventional Group

Eligibility Criteria

• Age: 1 Hour - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Nadir Yalçın

Ankara, TR, 06100, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Yalcin N, Kasikci M, Celik HT, Allegaert K, Demirkan K, Yigit S. Impact of clinical pharmacist-led intervention for drug-related problems in neonatal intensive care unit a randomized controlled trial. Front Pharmacol. 2023 Aug 14;14:1242779. doi: 10.3389/fphar.2023.1242779. eCollection 2023.

  PMID: 37645440 DERIVED

• Yalcin N, Kasikci M, Celik HT, Allegaert K, Demirkan K, Yigit S, Yurdakok M. Development and validation of a machine learning-based detection system to improve precision screening for medication errors in the neonatal intensive care unit. Front Pharmacol. 2023 Apr 14;14:1151560. doi: 10.3389/fphar.2023.1151560. eCollection 2023.

  PMID: 37124199 DERIVED

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Nadir Yalçın, MSc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadir Yalçın, MSc

CONTACT

+905356849300; nadir.yalcin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 25, 2021
• Study Start: February 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-05

Locations

TU (1)