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临床试验/CTRI/2023/08/056687
CTRI/2023/08/056687已完成不适用

Evaluation Of Trend and Rationale of Prescription, Drug Utilization Pattern and Safety in Sick Newborn Care Unit of a Tertiary Care Hospital in Uttarakhand: An Observational Cross-Sectional Study

Government Doon Medical College1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2023年8月28日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
270
试验地点
1
主要终点
drug utilization patterns in the Sick Newborn Care Unit using WHO drug use indicators

研究概览

简要总结

The Neonatal Mortality Rate (NMR) In developing countries is 27 deaths per 1,000 births. In India its 25 per 1,000 live births and in Uttarakhandit is 32.4 per 1000 live births {National Family Health Survey -5 (NFHS-5) report}. Children with life threatening conditions need intensive care & treatment in Sick Newborn Care Units (SNCUs) with more drug orders (polypharmacy). There is paucity of data related to drug utilization patterns, adverse drug reactions, drug-drug interactions, cost and rationale of prescribed medications and length of stay of neonates in SNCUs of Uttarakhand state. A observational cross-sectional study will be conducted in the Department of Pharmacology in collaboration with the Department of Paediatrics at Government Doon Medical College and Hospital for a duration of 12 months.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • Neonates admitted to SNCU and receiving at least 1 drug.

排除标准

  • Neonates admitted in the SNCU exclusively for oxygen therapy, vaccines, blood products, electrolytes, total parenteral nutrition and intravenous hydration.

结局指标

主要结局

drug utilization patterns in the Sick Newborn Care Unit using WHO drug use indicators

时间窗: The Drug utilization will be recorded at the time of discharge of each patient and The WHO indicators will be assessed at the end of one year for the entire data

次要结局

  • To evaluate potential drug interactions of drugs prescribed in SNCU(1 year)
  • To monitor adverse drug reactions of drugs prescribed in SNCU(1 year)
  • To evaluate rationale of drugs prescribed in SNCU(1 year)
  • To evaluate length of stay in SNCU of GDMC Hospital(1 year)
  • To evaluate cost of drug therapy in SNCU based on cost per DDD(1 year)

研究者

发起方
Government Doon Medical College
申办方类型
Government medical college

研究点 (1)

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