Determination of Heart Rate in Infants Needing Resuscitation at Birth

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.

Study Overview

• Status: Completed
• Conditions: Perinatal Asphyxia
• Intervention / Treatment: Other: Heart rate assessment (stethoscope); Other: Heart assessment (umbilical cord palpation)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ethiopia
  • Addis Ababa, Ethiopia
    • St. Luke Catholic Hospital, Wolisso, Ethiopia
• Italy
  • Padova, Italy
    • University of Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Heart rate assessed by using a stethoscope (auscultation); Heart rate will be assessed by using a stethoscope (auscultation) in newborn infants immediately after birth	Other: Heart rate assessment (stethoscope); Immediately after birth heart rate will be evaluated by auscultation
ACTIVE_COMPARATOR: Heart rate assessed by palpation of the umbilical cord; Heart rate will be assessed by palpation of the umbilical in newborn infants immediately after birth	Other: Heart assessment (umbilical cord palpation); Immediately after birth heart rate will be evaluated by palpation of the umbilical cord

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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 ECG	1 minute

Secondary Outcome Measures

Outcome Measure	Time Frame
Time of the first breath	20 minutes
Time of regular breathing	20 minutes
Mortality rate	1 month (during hospitalization)
Number (%) of asphyxiated neonates	5 min
Age at discharge/death (days)	1 month

Collaborators and Investigators

• Sponsor: University Hospital Padova
• Collaborators: CUAMM Doctors with Africa, Padova, Italy; St. Luke Catholic Hospital, Wolisso, Ethiopia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 25, 2019
• Primary Completion (ACTUAL): April 2, 2019
• Study Completion (ACTUAL): April 2, 2019

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: February 23, 2019
• First Posted (ACTUAL): February 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Death; Asphyxia
• Other Study ID Numbers: university of padova

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No