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临床试验/NCT05844709
NCT05844709已完成不适用

Effectiveness of Nursing Care Bundle for the Prevention of Intraventricular Hemorrhage in Preterm Infants

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2022年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
178
试验地点
1
主要终点
The incidence of intraventricular hemorrhage

研究概览

简要总结

Existing measures to prevent intraventricular hemorrhage in preterm infants include preventing premature delivery, pre-natal administration of corticosteroid, active treatment of chorioamnionitis, and improvement of postnatal resuscitation and transfer process. Many overseas studies show that nursing care can reduce the risk of intraventricular hemorrhage and death, but there is no such study in Taiwan.

Objective: to explore the effect of bundle nursing care on prevention of IVH in premature infants.

详细描述

A quasi-experimental study design was employed and a total of 230 preterm infants with birth weight less than 1,500 g or gestational age ≤30 weeks will be recruited at the neonatal intensive care unit of National Taiwan University Hospital. The infants will be divided into 200 in the control group and 30 in the experimental group. Enrollment began after approval was granted by the Institutional Review Board. Eligible hospitalized preterm infants that met the inclusion criteria from January 2017 to December 2029 were selected for the control group by retrospective cohort and matched by the gestational age, birth weight and delivery method with the experimental group. The experimental group received bundle nursing care within 3 days after birth in addition to routine nursing care after consent was given and the informed consent form was signed. The study tools include 1. Intervention Tools: small towel or head positioning pillow (Tortle Midliner) and timer; 2. Data collection: Self-created questionnaire on awareness and behavior for preventing intraventricular hemorrhage in preterm infants in nurses, medical record and bundle care implementation record. The data were analyzed by descriptive statistics, t-test, Chi-square test and Logistic regression using SPSS 26 statistical software. The expected results are reduction in the incidence of intraventricular hemorrhage, the length of stay in the intensive care unit and mortality.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
1 Day 至 1 Month(Child)
性别
All
接受健康志愿者

入选标准

  • Inborn Preterm infants
  • Preterm infants with birth weight less than 1,500 g or gestational age ≤30 weeks

排除标准

  • Preterm infants with congenital malformations
  • Genetic syndromes
  • Congenital infections of the TORCHS group(syphilis, rubella, herpes, toxoplasmosis, and cytomegalovirus)
  • Resuscitation and Pneumothorax at birth.

结局指标

主要结局

The incidence of intraventricular hemorrhage

时间窗: 168 postnatal hours

Grading of Intraventricular Hemorrhage

次要结局

  • Mortality(From date of admission until the date of death from any cause up to 4 postnatal weeks)
  • The length of stay in the intensive care unit(From date of admission until the date of leave Neonatal intensive care unit up to 48 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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