Efficacy of Early Administration of Hydrocortisone in Shock in Preterm Neonates of Less Than 1,500 g
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Shock resolution
研究概览
简要总结
The goal of this clinical trial is to determine the effectiveness of early use of hydrocortisone (since the diagnosis of shock) for its resolution within the first 72 hours in premature infants under 1,500 g. The main questions it aims to answer are:
- Does the early use of hydrocortisone help solve shock in preterm infants under 1500 g faster than the standard treatment?
- Does the early use of hydrocortisone help prevent death within the first seven days of presentation of shock in comparison to premature infants who receive regular treatment?
Researchers will compare the early use of hydrocortisone plus the standard treatment to solve shock against just standard treatment.
Participants will:
- Be randomized to receive standard treatment for shock according to their neonatologist or this standard treatment plus hydrocortisone as soon as the diagnosis is done and treatment is started.
- Be followed either until shock is solved or if they present death due to this event of shock.
详细描述
WORK STRATEGY:
PHASE I:
-
Initially, the main investigators carried out an information campaign aimed at neonatologists in the Neonatal Intensive Care Unit to unify criteria on the diagnosis of shock, provide information on current developments in treatment of premature newborns, and publicize the characteristics of the research project.
-
A shock algorithm was developed according to the most recent evidence-based recommendations to unify criteria for the diagnosis of shock in premature infants and its treatment according to the pathophysiology.
-
The algorithm is available on the computers of each of the physicians in the NICU.
-
The algorithm has been disseminated to all physicians through several talks during their shift.
-
This algorithm was also printed on 1.5 x 2 meter posters, which were placed in the NICU physicians' offices for quick access.
-
All physicians have been invited to collaborate on the research project.
-
On the other hand, an information campaign has been carried out aimed at the nursing staff of the NICU with the aim of updating their knowledge on the correct measurement of blood pressure in premature newborns and unifying criteria.
-
Posters were made with updated information on blood pressure measurement.
-
These posters were printed on 1.2 x 70 cm sheets. The posters were placed in strategic locations in the NICU so that the information was readily available to staff.
-
An informative talk was given to the nursing staff of both services and all three shifts about the research project and the importance of their participation in the early detection of shock symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 0 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm babies of 1,500 g or less
- •Diagnosis of shock by attending physician during their first 14 days of life
排除标准
- •Major physical malformations that compromise life itself.
- •Preterm newborns with probable Congenital Adrenal Hyperplasia
研究组 & 干预措施
Preterm neonates in shock who receive regular treatment.
The treatment this group receives is determined by the attending neonatologist. It may o may not include Hydrocortisone at some point of the evolution of the disease.
干预措施: Vasoactive drug therapies (Other)
结局指标
主要结局
Shock resolution
时间窗: 72 hours
The patient is hemodynamically stable and no longer requires vasoactive support.
次要结局
- Mortality.(Seven days.)