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临床试验/NCT03913533
NCT03913533撤回不适用

Standard 6-sec Method Versus Tap-based Application Method to Assess Heart Rate at Birth - a Randomized Controlled Trial

University of Alberta2 个研究点 分布在 1 个国家开始时间: 2019年12月16日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Time to obtain Heart rate

研究概览

简要总结

Some newborn babies have difficulty breathing at birth and need help. When babies need help with breathing the clinical team, the team measures heart rate using a stethoscope to check its heart rate and figure out what kind of help they will need. If the heart rate is too low, the clinical team will begin to inflate the baby's lung. Knowing the baby's heart rate quickly is important but the stethoscope is inaccurate, and might delay start of resuscitation. Using a smartphone app that uses screen tapping with a stethoscope could allow heart rate to be measured much faster compared to the stethoscope and allow the clinical team to support the baby's needs better immediately after birth.

详细描述

Purpose

Nearly 10% of all infants born worldwide require respiratory support at birth and birth asphyxia remains one of the leading causes of infant morbidity and mortality. Neonatal resuscitation is the most effective strategy to deal with this condition. Moreover, an infant's heart rate (HR) is the most significant clinical parameter used to assess the need for and response to neonatal resuscitation. Currently, a newborn's HR is determined by auscultating or palpating of the umbilical cord. Although auscultation is more precise compared to palpation, both methods are inaccurate and tend to underestimate HR. The current resuscitation guidelines also recommend using electrocardiogram (ECG) and pulse oximetry, which allow for continuous monitoring, however are slow to apply and detect HR compared to stethoscopes. During neonatal resuscitation, an infant's HR is necessary to initiate resuscitation and to monitor the effectiveness of each intervention and therefore it becomes essential to accurately and quickly assess an infant's HR during this process. If HR is detected slowly or inaccurately, there is an increased risk that necessary interventions are not started or that certain interventions are prolonged, which could lead to increased morbidity and mortality of the infants. The recent advances in technology, namely the development of a smartphone tap application for HR assessment is promising as a novel tool for quick and accurate HR detection during neonatal resuscitation.

Hypothesis

The use of a tap-based smartphone application will be faster and more accurate when compared to standard auscultation with the 6-sec method to assess HR.

Justification

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

盲法说明

the outcome assessed will be masked to group allocation

入排标准

年龄范围
— 至 5 Minutes(Child)
性别
All
接受健康志愿者

入选标准

  • All newborn infants delivered in the Royal Alexandra Hospital (RAH) 22+0-41+6 weeks gestation.

排除标准

  • Infants will be excluded if parents refused to consent to the study.

结局指标

主要结局

Time to obtain Heart rate

时间窗: within the first 60 seconds form birth

Time to obtain Heart rate form birth

次要结局

  • Accuracy of heart rate assessment using either technique(within the first 60 seconds form birth)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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