Determination of Heart Rate in Infants Needing Resuscitation at Birth

NCT03854435 | Completed

• 1 other identifier: University of Padova
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

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.

Conditions

Perinatal Asphyxia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Heart rate assessed by using a stethoscope (auscultation)

EXPERIMENTAL

Heart rate will be assessed by using a stethoscope (auscultation) in newborn infants immediately after birth

Other: Heart rate assessment (stethoscope)

Heart rate assessed by palpation of the umbilical cord

ACTIVE COMPARATOR

Heart rate will be assessed by palpation of the umbilical in newborn infants immediately after birth

Other: Heart assessment (umbilical cord palpation)

Interventions

Heart rate assessment (stethoscope) OTHER

Immediately after birth heart rate will be evaluated by auscultation

Heart rate assessed by using a stethoscope (auscultation)

Heart assessment (umbilical cord palpation) OTHER

Immediately after birth heart rate will be evaluated by palpation of the umbilical cord

Heart rate assessed by palpation of the umbilical cord

Eligibility Criteria

• Age: Up to 30 Days
• Gender Eligibility Details: Meles and females will be enrolled
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• inborn infants (and)
• need for resuscitation (and)
• 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.

You may not qualify if:

• Major congenital malformations;
• Parental refusal to participate to the study.

Sponsors & Collaborators

• University Hospital Padova: lead
• CUAMM Doctors with Africa, Padova, Italy: collaborator
• St. Luke Catholic Hospital, Wolisso, Ethiopia: collaborator

Study Sites (2)

St. Luke Catholic Hospital, Wolisso, Ethiopia

Addis Ababa, Ethiopia

Location

University of Padova

Padua, Italy

Location

Related Publications (1)

• 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.

  PMID: 32222255 DERIVED

MeSH Terms

Interventions

Stethoscopes

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 26, 2019
• Study Start: February 25, 2019
• Primary Completion: April 2, 2019
• Study Completion: April 2, 2019
• Last Updated: October 31, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1); IT (1)