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临床试验/NCT03854435
NCT03854435已完成不适用

Determination of Heart Rate in Infants Needing Resuscitation at Birth

University Hospital Padova2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2019年2月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Degree of agreement of herat rate obtained by auscultation or palpation (HR: <60bpm/60-100bpm/>100bpm) obtained by auscultation or palpation compared with the HR as determined by ECG

研究概览

简要总结

Algorithms for neonatal resuscitation adapted to low resource settings include HR evaluation by auscultation or umbilical cord palpation at about one minute of life.

Previous studies conducted in high resource settings showed that auscultation of the precordium is more accurate than umbilical palpation to assess HR of healthy infants at birth.The last versions of the American Heart Association and the European Resuscitation Council Guidelines on Neonatal resuscitation suggest that "during resuscitation of term and preterm newborns, the use of 3-lead ECG for the rapid and accurate measurement of the newborn's heart rate may be reasonable". However, this remains a weak recommendation with a very-low-quality evidence.

In low resource countries, a stethoscope is rarely available and palpation of the umbilical pulse is the method used for detecting HR. Although this is preferable to other palpation sites (i.e. femo-ral and brachial artery), there is a high likelihood of underestimating HR with palpation of the umbilical pulse in healthy infants.

The accuracy of assessing HR by auscultation and umbilical palpation in newborn infants requir-ing resuscitation remains unknown.

To the investigator's knowledge, there are not previous studies that have compared the accuracy of HR estima-tion by auscultation vs. umbilical palpation in newborn infants needing resuscitation This study was designed to compare two different methods (auscultation and umbilical cord pal-pation) of HR estimation in newborn infants needing resuscitation, in order to determine which method is most suitable for use in clinical practice.

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)

入排标准

年龄范围
— 至 30 Days(Child)
性别
All
接受健康志愿者

入选标准

  • inborn infants (and)
  • need for resuscitation (and)
  • parental consent; a written informed consent will be obtained by a member of the neonatal staff involved in the study from a parent or guardian at maternal admission to the obstetrical ward or prior to delivery.

排除标准

  • Major congenital malformations;
  • Parental refusal to participate to the study.

研究组 & 干预措施

Heart rate assessed by using a stethoscope (auscultation)

Experimental

Heart rate will be assessed by using a stethoscope (auscultation) in newborn infants immediately after birth

干预措施: Heart rate assessment (stethoscope) (Other)

Heart rate assessed by palpation of the umbilical cord

Active Comparator

Heart rate will be assessed by palpation of the umbilical in newborn infants immediately after birth

干预措施: Heart assessment (umbilical cord palpation) (Other)

结局指标

主要结局

Degree of agreement of herat rate obtained by auscultation or palpation (HR: <60bpm/60-100bpm/>100bpm) obtained by auscultation or palpation compared with the HR as determined by ECG

时间窗: 1 minute

次要结局

  • Mortality rate(1 month (during hospitalization))
  • Time of regular breathing(20 minutes)
  • Age at discharge/death (days)(1 month)
  • Number (%) of asphyxiated neonates(5 min)
  • Time of the first breath(20 minutes)

研究者

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

Daniele Trevisanuto

Professor

University Hospital Padova

研究点 (2)

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