Ignite Creation Date:
2024-05-06 @ 12:49 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03854435
Status:
COMPLETED
Last Update Posted:
2019-10-31
First Post:
2019-01-29
Brief Title:
Determination of Heart Rate in Infants Needing Resuscitation at Birth
Sponsor:
University Hospital Padova
Organization:
University Hospital Padova
Study Overview
Official Title:
Determination of Heart Rate in Infants Needing Resuscitation at Birth
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 birthThe 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 newborns 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 ie 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 investigators 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
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 birthThe 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 newborns 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 ie 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 investigators 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None