Drug-Related Problems in Neonatal Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 512
- 试验地点
- 1
- 主要终点
- Score for Neonatal Acute Physiology and Perinatal Extension Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Hour 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
İnterventional Group
干预措施: Clinical Pharmacist Intervention (Drug)
结局指标
主要结局
Score for Neonatal Acute Physiology and Perinatal Extension Score
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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.)
研究者
Nadir Yalçın
Principal Investigator
Hacettepe University