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临床试验/NCT02779062
NCT02779062已完成不适用

ALTE Study: Interviews With Parents of Infants Seen in an Emergency Department

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Parental comfort level with disposition home from emergency department

研究概览

简要总结

Infants sometimes experience sudden symptoms such as breathing irregularities or limpness that frighten parents and prompt them to seek emergency medical care. While few of these episodes are truly life-threatening and require hospital admission, some parents may have been so frightened that they will resist returning home from the emergency department with their baby even if the objective risk is extremely small. Study subjects (parents of infants with an apparent life threatening event) will be contacted and interviewed. Investigators want to learn whether or not study subjects would accept returning home after a brief period of observation in the emergency department if the physician determines that it is safe to do so.

详细描述

An apparent life-threatening event (ALTE) refers to the sudden occurrence in an infant of symptoms such as breathing irregularities, stiffness, or limpness, that appear frightening to caretakers, prompting them to seek medical care. ALTE was first defined in 1986 by an NIH consensus panel. Population-based epidemiologic studies have reported a range of 2.5 to 9.4 ALTE admissions per 1000 live births.

While few ALTEs are truly life-threatening, both clinicians and parents may assume that the infant's life was-and may still be-in danger until proven otherwise. Since the actual risk of an adverse outcome in a well-appearing ALTE patient is unknown, this concern often leads to an extensive diagnostic evaluation and hospitalization to rule out serious occult pathology even when a patient appears well on presentation and has an unremarkable clinical assessment.

Nonspecific inpatient diagnostic evaluations can harm patients by causing complications from invasive testing, false-positive test results, and vulnerable child syndrome. Given these risks and the low probability that such testing will identify a treatable diagnosis in a well-appearing infant, the American Academy of Pediatrics has established a Guideline Committee on ALTEs to develop recommendations for the management of these patients. Specifically, the Committee is formulating criteria to define a low-risk group of infants presenting with ALTE who may be safely discharged after minimal diagnostic testing and a few hours of observation. While an evidence-based clinical guideline has the potential to reduce unnecessary testing and hospital admissions, anecdotal evidence suggests that some parents may have been so frightened by the event that they will resist returning home with their baby even if the objective risk is extremely small. To gather data about parental attitudes, the investigators propose to survey subjects (parents of infants who have experienced an ALTE) to learn whether or not they would accept returning home after a brief period of observation in the emergency department if the physician determines that it is safe to do so. This survey will focus on subject's willingness to forgo admission to the hospital when the risks associated with hospitalization (e.g., hospital-acquired infection, complications of invasive diagnostic procedures) might outweigh the risk of a recurrent ALTE or serious underlying condition. Subject's with an obvious need for admission based on the initial clinical assessment will be excluded, since discharge home would not be an option. Study findings will inform efforts to develop clinical guidelines for the management of an ALTE that take into account both parental attitudes and objective evidence. Without both types of data, implementation of such a guideline will be problematic.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult parents of an infant with an ALTE event

排除标准

  • Unwilling to sign informed consent document

结局指标

主要结局

Parental comfort level with disposition home from emergency department

时间窗: Subject will be asked to describe their experiences in the ER when their infant was undergoing an evaluation following an apparent life-threatening event. Subject will be interviewed face-to-face or by telephone within 3 years of the event.

Subject response (yes or no) to the following question: Would you have felt comfortable returning home from the emergency department with your baby (rather than admitting baby to the hospital overnight) if the medical evaluation in the emergency department had determined that it would be safe to do so? This question will be asked within the context of a series of questions addressing the subject's experience following the apparent life-threatening event of their infant.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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