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临床试验/CTRI/2025/07/091567
CTRI/2025/07/091567尚未招募不适用

Assessment of potential drug-drug interactions in neonatal intensive care unit: a retrospective study

NGSM Institute of Pharmaceutical Sciences1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2025年8月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
240
试验地点
1
主要终点
Common DDIs among neonates can be identified and categorized based on severity.

研究概览

简要总结

Introduction:

A neonate, or newborn infant under 28 days old, undergoes critical developmental changes and is highly vulnerable to health risks, including adverse drug events. Infants in the NICU are exposed to a large number of medications that increase the risk of causing potential drug-drug interactions and thereby lead to adverse drug events.

Objectives:

• To assess the potential drug-drug interactions among neonates admitted to NICU department.

• To assess the risk category of potential drug-drug interactions among neonates.

Methodology:

A retrospective study will be conducted in  NICU of Justice K.S. Hegde Hospital for 8 months, with a sample size of 240 neonates (2020–2024) using convenience sampling. Data will be collected on demographics, drugs prescribed, and potential DDIs analyzed and categorized using UpToDate and Medscape.

Inclusion criteria:

• Neonates (<28 days of age) who have been admitted in NICU department at K.S. Hegde hospital.

• Neonates prescribed with at least 2 medications.

• All neonates, both preterm and term will be included

• Neonate with clear and complete patient data will be included.

Exclusion criteria:

• Neonates born in any hospital other than Justice K.S. Hegde charitable Hospital will be excluded.

Statistical analysis:

The data will be entered in MS excel and analysed using SPSS [V29.0]. The continuous data will be expressed as mean +SD and categorical values will be presented in frequency [%]. Data will also be represented as graphs or diagrams

outcome:

Common DDIs among neonates can be identified and categorized based on severity. Length of hospital stay can be corelated with the number of DDIs.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Neonates(less than 28days) who have been admitted in NICU department at KS Hegde hospital, Neonates prescribed with at least 2 medications, All neonates both preterm and term will be included, Neonates with clear and complete patient data will be included.

排除标准

  • Neonates born in any other hospital other than Justice KS Hedge Charitable hospital will be excluded.

结局指标

主要结局

Common DDIs among neonates can be identified and categorized based on severity.

时间窗: 8 months

次要结局

  • Length of hospital stay can be correlated with the number of DDIs.(8 months)

研究者

发起方
NGSM Institute of Pharmaceutical Sciences
申办方类型
Other [Academic Institute]
责任方
Principal Investigator
主要研究者

Leona Valeria Pais

NGSM Institute of Pharmaceutical Sciences

研究点 (1)

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