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Drug-Related Problems in Neonatal Patients

Primary Purpose

Neonatal Intensive Care Unit, Medication Errors, Drug-Related Problems

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Clinical Pharmacist Intervention
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neonatal Intensive Care Unit

Eligibility Criteria

1 Hour - 28 Days (Child)All SexesDoes not accept 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

Sites / Locations

  • Nadir YalçınRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Experimental

Arm Label

Observational Group

Control (Validation) Group

İnterventional Group

Arm Description

Outcomes

Primary Outcome Measures

Score for Neonatal Acute Physiology and Perinatal Extension Score
Score for Neonatal Acute Physiology and Perinatal Extension Score is predictor of mortality in neonates.
Neonatal Therapeutic Intervention Scoring System
It is a therapy-based severity of illness (morbidity) assessment index.
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.
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.

Secondary Outcome Measures

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.
The Drug Interaction Probability Scale
This scale uses a series of questions relating to the potential drug interaction to estimate a probability score.
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.
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.

Full Information

First Posted
May 11, 2021
Last Updated
September 1, 2021
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04899960
Brief Title
Drug-Related Problems in Neonatal Patients
Official Title
Drug-Related Problems in Neonatal Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
November 1, 2021 (Anticipated)
Study Completion Date
November 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Intensive Care Unit, Medication Errors, Drug-Related Problems, Adverse Drug Event, Drug-Drug Interaction, Clinical Pharmacy, Machine Learning

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
512 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Observational Group
Arm Type
No Intervention
Arm Title
Control (Validation) Group
Arm Type
No Intervention
Arm Title
İnterventional Group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Clinical Pharmacist Intervention
Intervention Description
Prevention of drug-related problems by clinical pharmacist in neonatal intensive care unit.
Primary Outcome Measure Information:
Title
Score for Neonatal Acute Physiology and Perinatal Extension Score
Description
Score for Neonatal Acute Physiology and Perinatal Extension Score is predictor of mortality in neonates.
Time Frame
Through study completion, an average of 1 year.
Title
Neonatal Therapeutic Intervention Scoring System
Description
It is a therapy-based severity of illness (morbidity) assessment index.
Time Frame
Through study completion, an average of 1 year.
Title
Neonatal Early-Onset Sepsis Risk Score
Description
It is use first week of life for determined sepsis risk with gestational age, highest maternal antepartum temperature, duration of rupture of membranes, etc.
Time Frame
Through study completion, an average of 1 year.
Title
Neonatal Nutrition Screening Tool
Description
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.
Time Frame
Through study completion, an average of 1 year.
Secondary Outcome Measure Information:
Title
Neonatal Adverse Event Severity Scale
Description
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.
Time Frame
Through study completion, an average of 1 year.
Title
The Drug Interaction Probability Scale
Description
This scale uses a series of questions relating to the potential drug interaction to estimate a probability score.
Time Frame
Through study completion, an average of 1 year.
Title
Adverse Drug Reactions Algorithm for Infants
Description
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.
Time Frame
Through study completion, an average of 1 year.
Title
National Aeronautics and Space Administration Task Load Index
Description
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.
Time Frame
Through study completion, an average of 1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nadir Yalçın, MSc
Phone
+905356849300
Email
nadir.yalcin@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadir Yalçın, MSc
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nadir Yalçın
City
Ankara
State/Province
TR
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadir Yalçın, MSc
Phone
+903123052043
Email
nadir.yalcin@hotmail.com

12. IPD Sharing Statement

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Drug-Related Problems in Neonatal Patients

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