Determination of Heart Rate in Infants Needing Resuscitation at Birth

Perinatal Asphyxia Clinical Trial

Official title:

Determination of Heart Rate in Infants Needing Resuscitation at Birth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03854435
• Other study ID #: University of Padova
• Status: Completed
• Phase: N/A
• Start date: February 25, 2019
• Est. completion date: April 2, 2019

Study information

• Verified date: October 2019
• Source: University Hospital Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2, 2019
• Est. primary completion date: April 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Days

Eligibility

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.

Related Conditions & MeSH terms

• Asphyxia
• Perinatal Asphyxia

Intervention

Other:
• Heart rate assessment (stethoscope)
Immediately after birth heart rate will be evaluated by auscultation
• Heart assessment (umbilical cord palpation)
Immediately after birth heart rate will be evaluated by palpation of the umbilical cord

Locations

Country	Name	City	State
Ethiopia	St. Luke Catholic Hospital, Wolisso, Ethiopia	Addis Ababa
Italy	University of Padova	Padova

Sponsors (3)

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

Countries where clinical trial is conducted

Ethiopia,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		1 minute
Secondary	Time of the first breath		20 minutes
Secondary	Time of regular breathing		20 minutes
Secondary	Mortality rate		1 month (during hospitalization)
Secondary	Number (%) of asphyxiated neonates		5 min
Secondary	Age at discharge/death (days)		1 month