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临床试验/NCT01229384
NCT01229384撤回不适用

Randomized Controlled Trial Comparing Standard Versus Positive Pressure Nebulization in Infants With Bronchiolitis to Reduce Hospital Admissions

Phoenix Children's Hospital0 个研究点目标入组 200 人开始时间: 2011年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
200
主要终点
Hospitalization Rates

研究概览

简要总结

Hypothesis: That administration of nebulized therapy for bronchiolitis when using positive airway pressure is superior to standard mask ventilation in reducing hospital admissions.

Bronchiolitis is a lower respiratory tract infection (LRTI) syndrome caused by a variety of different viruses. It is the most common LRTI in children under 24 months old. Multiple studies have documented variation in treatment, hospitalization rates, and length of hospital stay for bronchiolitis, suggesting a lack of consensus and an opportunity to improve care for this common disorder.

Research to determine optimal delivery methods of respiratory medications that may augment oxygenation by decreasing atelectasis (Lung cell collapse) and increasing oxygen saturation have not been done. Currently bronchodilators are delivered through a passive process, inhaled as they are nebulized (made from liquid into gas) into a face mask. This study will evaluate whether using a newly developed positive pressure nebulization device that uses pressure to expand lung cells and, hypothetically, deliver the medication better, improves oxygenation by reducing atelectasis (lung cell collapse) to decrease hospitalization in infants with moderate to severe bronchiolitis.

Positive pressure nebulization is a relatively new adaptation of a previously existing modality, and is already currently in use here at PCH.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Care Provider)

入排标准

年龄范围
2 Months 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants 2-24 months with moderate to severe bronchiolitis

排除标准

  • Those outside the age range of 2-24 months, or less than postconceptual age of 48weeks for premature infants
  • Those with comorbid conditions such as cyanotic heart disease, home oxygen use, tracheostomy use, or other serious medical conditions.
  • Those with history of apnea

研究组 & 干预措施

Standard Nebulization

Active Comparator

Current standard of administering nebulized medications without positive airway pressure

干预措施: Standard passive nebulization of respiratory medications (Device)

Positive Airway Pressure Nebulization

Experimental

Will administer nebulized medications using Positive Airway Pressure Nebulization

干预措施: Positive Airway Pressure nebulization (Device)

结局指标

主要结局

Hospitalization Rates

时间窗: 2 weeks

Will measure rate of hospitalization of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.

次要结局

  • Change in bronchiolitis Score(day of presentation)
  • Change in Oxygen Saturation(Day of presentation)
  • Intensive Care Unit Admission Rate(day of presentation)
  • Length of Stay(To be determined)
  • Unscheduled Return to the Emergency Department(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark Hostetler

Principal Investigator

Phoenix Children's Hospital

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