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Determination of Heart Rate in Infants Needing Resuscitation at Birth

Determination of Heart Rate in Infants Needing Resuscitation at Birth

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03854435
Enrollment
60
Registered
2019-02-26
Start date
2019-02-25
Completion date
2019-04-02
Last updated
2019-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perinatal Asphyxia

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 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.

Interventions

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

Sponsors

CUAMM Doctors with Africa, Padova, Italy
CollaboratorUNKNOWN
St. Luke Catholic Hospital, Wolisso, Ethiopia
CollaboratorUNKNOWN
University Hospital Padova
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 30 Days
Healthy volunteers
No

Inclusion criteria

1. inborn infants (and) 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

1. Major congenital malformations; 2. Parental refusal to participate to the study.

Design outcomes

Primary

MeasureTime frame
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 ECG1 minute

Secondary

MeasureTime frame
Time of the first breath20 minutes
Time of regular breathing20 minutes
Mortality rate1 month (during hospitalization)
Number (%) of asphyxiated neonates5 min
Age at discharge/death (days)1 month

Countries

Ethiopia, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026