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
| Type | Name | Description |
|---|---|---|
| OTHER | Heart rate assessment (stethoscope) | Immediately after birth heart rate will be evaluated by auscultation |
| OTHER | Heart 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.