Efficacy of Magnesium Sulfate Bolus in Pediatric Patients With Bronchiolitis
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- To evaluate the effect of this therapy on clinical respiratory status
研究概览
简要总结
The purpose of this study is to more rigorously evaluate the response to a single bolus of magnesium sulfate in a population of patients with moderate to severe bronchiolitis. The primary outcome will be to evaluate the effect of this therapy on clinical respiratory status. Secondary outcomes of interest will include the incidence of adverse effects and safety profile of magnesium bolus use in this population.
详细描述
This randomized placebo-controlled pilot study is designed to evaluate the above referenced outcomes. Study drug initiation will occur in the local pediatric intensive care unit in patients with a clinical diagnosis of bronchiolitis and whose parent/LAR consents for their participation. Our goal is to enroll and evaluate a total of 40 patients.
Upon obtaining informed consent, the participant will receive an enrollment history and physical to include: baseline Modified Pulmonary Index Score (MPIS), blood pressure, vital signs, and epidemiologic data. The participant will then receive either a bolus of 50mg/kg Magnesium Sulfate (MgSO4) or normal saline as placebo medication over twenty minutes. Vital signs and MPIS will be monitored according to the study schedule, for a total of six hours. During the period of monitoring subjects will not receive additional bronchodilators unless otherwise deemed clinically necessary by the subject's attending physician. If administered, these will be recorded by investigative team.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blinding will be done in the pharmacy using a pre-developed randomization table. Study medication, whether MgSO4 or placebo, will be prepared by a study pharmacist and sent to the nursing/clinical staff for administration labelled as "study drug". Unblinding, if clinically indicated, can be provided to the treatment team but it is not anticipated that this will be required.
入排标准
- 年龄范围
- 1 Month 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants under 12 months of age
- •Admitted to the pediatric intensive care unit
- •Moderate/severe bronchiolitis using MPIS
- •Less than 24 hours of admission to the PICU
- •Parent/LAR consents for infant to participate
排除标准
- •Patients with the following conditions are ineligible: chronic lung disease, unrepaired congenital heart disease, and cyanotic heart disease.
研究组 & 干预措施
Magnesium Sulfate
The patient will receive a bolus of 50mg/kg MgSO4 over twenty minutes.
干预措施: Magnesium Sulfate (Drug)
Placebo
The patient will receive a bolus of Normal Saline over twenty minutes.
干预措施: Magnesium Sulfate (Drug)
结局指标
主要结局
To evaluate the effect of this therapy on clinical respiratory status
时间窗: 6 hours post bolus of medication versus placebo
MPIS will be used to follow respiratory status
次要结局
- Identify the incidence of adverse effects and safety profile of magnesium sulfate(6 hours post bolus of medication versus placebo)
研究者
John W Berkenbosch
Professor
University of Louisville