Determination of Heart Rate in Infants Needing Resuscitation at Birth

Not Applicable

Completed

• Conditions: Perinatal Asphyxia
• Interventions: Other: Heart rate assessment (stethoscope); Other: Heart assessment (umbilical cord palpation)

• Registration Number: NCT03854435
• Lead Sponsor: University Hospital Padova

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-02-23
• Study Start: 2019-02-25
• Study First Posted: 2019-02-26
• Primary Completion: 2019-04-02
• Study Completion: 2019-04-02
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heart rate assessed by using a stethoscope (auscultation)	Heart rate assessment (stethoscope)	Heart rate will be assessed by using a stethoscope (auscultation) in newborn infants immediately after birth
Heart rate assessed by palpation of the umbilical cord	Heart assessment (umbilical cord palpation)	Heart rate will be assessed by palpation of the umbilical in newborn infants immediately after birth

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (2)

St. Luke Catholic Hospital, Wolisso, Ethiopia; 🇪🇹 Addis Ababa, Ethiopia

University of Padova; 🇮🇹 Padova, Italy