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Determination of Heart Rate in Infants Needing Resuscitation at Birth

Primary Purpose

Perinatal Asphyxia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Heart rate assessment (stethoscope)
Heart assessment (umbilical cord palpation)
Sponsored by
University Hospital Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Perinatal Asphyxia

Eligibility Criteria

undefined - 30 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Heart rate assessed by using a stethoscope (auscultation)

Heart rate assessed by palpation of the umbilical cord

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time of the first breath
Time of regular breathing
Mortality rate
Number (%) of asphyxiated neonates
Age at discharge/death (days)

Full Information

First Posted
January 29, 2019
Last Updated
October 30, 2019
Sponsor
University Hospital Padova
Collaborators
CUAMM Doctors with Africa, Padova, Italy, St. Luke Catholic Hospital, Wolisso, Ethiopia
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1. Study Identification

Unique Protocol Identification Number
NCT03854435
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 25, 2019 (Actual)
Primary Completion Date
April 2, 2019 (Actual)
Study Completion Date
April 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Padova
Collaborators
CUAMM Doctors with Africa, Padova, Italy, St. Luke Catholic Hospital, Wolisso, Ethiopia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Asphyxia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heart rate assessed by using a stethoscope (auscultation)
Arm Type
Experimental
Arm Description
Heart rate will be assessed by using a stethoscope (auscultation) in newborn infants immediately after birth
Arm Title
Heart rate assessed by palpation of the umbilical cord
Arm Type
Active Comparator
Arm Description
Heart rate will be assessed by palpation of the umbilical in newborn infants immediately after birth
Intervention Type
Other
Intervention Name(s)
Heart rate assessment (stethoscope)
Intervention Description
Immediately after birth heart rate will be evaluated by auscultation
Intervention Type
Other
Intervention Name(s)
Heart assessment (umbilical cord palpation)
Intervention Description
Immediately after birth heart rate will be evaluated by palpation of the umbilical cord
Primary Outcome Measure Information:
Title
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
Time Frame
1 minute
Secondary Outcome Measure Information:
Title
Time of the first breath
Time Frame
20 minutes
Title
Time of regular breathing
Time Frame
20 minutes
Title
Mortality rate
Time Frame
1 month (during hospitalization)
Title
Number (%) of asphyxiated neonates
Time Frame
5 min
Title
Age at discharge/death (days)
Time Frame
1 month

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Meles and females will be enrolled
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Major congenital malformations; Parental refusal to participate to the study.
Facility Information:
Facility Name
St. Luke Catholic Hospital, Wolisso, Ethiopia
City
Addis Ababa
Country
Ethiopia
Facility Name
University of Padova
City
Padova
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32222255
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.
Results Reference
derived

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Determination of Heart Rate in Infants Needing Resuscitation at Birth

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