Neonatal Intensive Care UnitNCT04899960
Drug-Related Problems in Neonatal Patients
A study testing Clinical Pharmacist Intervention in people with Neonatal Intensive Care Unit and Medication Errors, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 1 hour to 28 days
- Conditions the study is for
- Neonatal Intensive Care Unit, Medication Errors, Drug-Related Problems
- What is being tested?
- Clinical Pharmacist Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Nadir Yalçın
Ankara, TR, 06100
Nadir Yalçın, MSc, +903123052043, nadir.yalcin@hotmail.com
About this study
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
- Being tested
- Clinical Pharmacist Intervention
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Pharmacist InterventionDrug
Prevention of drug-related problems by clinical pharmacist in neonatal intensive care unit.
| Study group | Role | What they receive |
|---|---|---|
| Observational Group | No intervention | Not described |
| Control (Validation) Group | No intervention | Not described |
| İnterventional Group | Experimental | Not described Receives: Drug: Clinical Pharmacist Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score for Neonatal Acute Physiology and Perinatal Extension Score
Score for Neonatal Acute Physiology and Perinatal Extension Score is predictor of mortality in neonates.
Measured: Through study completion, an average of 1 year.
Neonatal Therapeutic Intervention Scoring System
It is a therapy-based severity of illness (morbidity) assessment index.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start1 Feb 2020
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neonatal Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 512 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadir Yalçın, Hacettepe University
- Investigators
- Nadir Yalçın, MSc, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899960
- Sponsor's protocol ID
- KA-20004
- Status last verified
- May 2021
- First submitted
- 11 May 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37645440Yalcin 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.
PubMed 37124199
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-Related Problems in Neonatal Patients
- ClinicalTrials.gov ID
- NCT04899960
- Acronym / sponsor ID
- KA-20004
- Conditions
- Neonatal Intensive Care Unit, Medication Errors, Drug-Related Problems, Adverse Drug Event, Drug-Drug Interaction, Clinical Pharmacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 512 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Observational Group | No intervention | – |
| Control (Validation) Group | No intervention | – |
| İnterventional Group | Experimental | Drug: Clinical Pharmacist Intervention |
Who may qualify
- Ages
- 1 hour to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Pharmacist InterventionPrevention of drug-related problems by clinical pharmacist in neonatal intensive care unit. | Drug | İnterventional Group |
Primary outcome
Score for Neonatal Acute Physiology and Perinatal Extension Score
Time frame: Through study completion, an average of 1 year.
Score for Neonatal Acute Physiology and Perinatal Extension Score is predictor of mortality in neonates.
Neonatal Therapeutic Intervention Scoring System
Time frame: Through study completion, an average of 1 year.
It is a therapy-based severity of illness (morbidity) assessment index.
Neonatal Early-Onset Sepsis Risk Score
Time frame: Through study completion, an average of 1 year.
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
Time frame: Through study completion, an average of 1 year.
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.
4 secondary outcomes
Neonatal Adverse Event Severity Scale
Time frame: Through study completion, an average of 1 year.
The Drug Interaction Probability Scale
Time frame: Through study completion, an average of 1 year.
Adverse Drug Reactions Algorithm for Infants
Time frame: Through study completion, an average of 1 year.
National Aeronautics and Space Administration Task Load Index
Time frame: Through study completion, an average of 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Derived from this study: PubMed 37645440Yalcin 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.
- Derived from this study: PubMed 37124199Yalcin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadir Yalçın, MSc principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Pharmacist Intervention in people with Neonatal Intensive Care Unit and Medication Errors, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadir Yalçın, MSc (+905356849300, nadir.yalcin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score for Neonatal Acute Physiology and Perinatal Extension Score (time frame: Through study completion, an average of 1 year.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04899960, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.