Clinical trial NCT03854435: Determination of Heart Rate in Infants Needing Resuscitation at Birth
Official title: Determination of Heart Rate in Infants Needing Resuscitation at Birth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Asphyxia
Lead sponsor: University Hospital Padova
Sponsor class: OTHER
Collaborators: name: CUAMM Doctors with Africa, Padova, Italy
name: St. Luke Catholic Hospital, Wolisso, Ethiopia
First posted: 2019-02-26
Enrollment: 60
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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 ECG
timeFrame: 1 minute
Secondary outcomes:
measure: Time of the first breath
timeFrame: 20 minutes
measure: Time of regular breathing
timeFrame: 20 minutes
measure: Mortality rate
timeFrame: 1 month (during hospitalization)
measure: Number (%) of asphyxiated neonates
timeFrame: 5 min
measure: Age at discharge/death (days)
timeFrame: 1 month
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: St. Luke Catholic Hospital, Wolisso, Ethiopia
city: Padova
country: Italy
facility: University of Padova
Study officials:
References:
citation: 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.