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临床试验/NCT05609773
NCT05609773招募中不适用

Comparing Intubation Rates in the Delivery Room by Interface

University of Illinois College of Medicine at Peoria1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2022年9月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
42
试验地点
1
主要终点
Comparing Intubation Rates in the Delivery Room by Interface

研究概览

简要总结

Although the majority of premature neonates < 30 weeks gestion require positive pressure ventilation (PPV) at birth, the optimal interface to provide PPV has not been determined. Preferably this support would be provided by non-invasive means to prevent the development of bronchopulmonary dysplasia. Resuscitation with a face mask, single nasal tube, nasal prongs, and/or LMA are all approved methods of resuscitation per NRP as of 2010. Face masks have been associated with more dead space, air leak and airway obstruction however are the most commonly used interface. Recently, the Trigeminal Cardiac Reflex has been described, which can be induced with the placement of a facemask, resulting in bradycardia and apnea. Bi-nasal prongs (RAM cannula) have been found in studies to be associated with lower intubation rates in the delivery room (down to 24 weeks gestation), less need for epinephrine, chest compressions, and subsequent invasive ventilation. In addition to the potential practical advantages of bi-nasal prong resuscitation, there is evidence to suggest that ventilation through the nose may stimulate the subepithelial receptors of the upper airways causing an increase in respiratory rate and depth.

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
0 Weeks 至 30 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • All resuscitated infants < 30 weeks' gestation born at OSF SFMC

排除标准

  • Diagnosis of congenital diaphragmatic hernia No PPV needed, or no resuscitation desired due to major congenital anomalies or peri- viable status

结局指标

主要结局

Comparing Intubation Rates in the Delivery Room by Interface

时间窗: 3 years

We hypothesize that there will be at least a 40% reduction in the rate of intubation for patients born \< 30 weeks' gestation when bi-nasal prongs are utilized for neonatal resuscitation vs face mask.

次要结局

未报告次要终点

研究者

发起方
University of Illinois College of Medicine at Peoria
申办方类型
Other
责任方
Sponsor

研究点 (1)

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