Clinical Trials Directory

Trials / Completed

CompletedNCT03854435

Determination of Heart Rate in Infants Needing Resuscitation at Birth

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
University Hospital Padova · Academic / Other
Sex
All
Age
30 Days
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
OTHERHeart rate assessment (stethoscope)Immediately after birth heart rate will be evaluated by auscultation
OTHERHeart assessment (umbilical cord palpation)Immediately after birth heart rate will be evaluated by palpation of the umbilical cord

Timeline

Start date
2019-02-25
Primary completion
2019-04-02
Completion
2019-04-02
First posted
2019-02-26
Last updated
2019-10-31

Locations

2 sites across 2 countries: Ethiopia, Italy

Source: ClinicalTrials.gov record NCT03854435. Inclusion in this directory is not an endorsement.