Determination of Heart Rate in Infants Needing Resuscitation at Birth
NCT ID: NCT03854435
Last Updated: 2019-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2019-02-25
2019-04-02
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Heart rate assessed by using a stethoscope (auscultation)
Heart rate will be assessed by using a stethoscope (auscultation) in newborn infants immediately after birth
Heart rate assessment (stethoscope)
Immediately after birth heart rate will be evaluated by auscultation
Heart rate assessed by palpation of the umbilical cord
Heart rate will be assessed by palpation of the umbilical in newborn infants immediately after birth
Heart assessment (umbilical cord palpation)
Immediately after birth heart rate will be evaluated by palpation of the umbilical cord
Interventions
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Heart rate assessment (stethoscope)
Immediately after birth heart rate will be evaluated by auscultation
Heart assessment (umbilical cord palpation)
Immediately after birth heart rate will be evaluated by palpation of the umbilical cord
Eligibility Criteria
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Inclusion Criteria
2. need for resuscitation (and)
3. 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.
Exclusion Criteria
2. Parental refusal to participate to the study.
30 Days
ALL
No
Sponsors
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CUAMM Doctors with Africa, Padova, Italy
UNKNOWN
St. Luke Catholic Hospital, Wolisso, Ethiopia
UNKNOWN
University Hospital Padova
OTHER
Responsible Party
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Daniele Trevisanuto
Professor
Locations
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St. Luke Catholic Hospital, Wolisso, Ethiopia
Addis Ababa, , Ethiopia
University of Padova
Padua, , Italy
Countries
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References
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Cavallin F, Cori MS, Negash S, Azzimonti G, Vento G, Putoto G, Trevisanuto D. Heart Rate Determination in Newborns at Risk for Resuscitation in a Low-Resource Setting: A Randomized Controlled Trial. J Pediatr. 2020 Jun;221:88-92.e1. doi: 10.1016/j.jpeds.2020.02.026. Epub 2020 Mar 25.
Other Identifiers
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University of Padova
Identifier Type: -
Identifier Source: org_study_id