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Completed

NCT Number: NCT03854435

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.

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Key information

Conditions

Age range

Up to 30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Luke Catholic Hospital, Wolisso, Ethiopia, Addis Ababa, Ethiopia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heart rate assessment (stethoscope)

Other

Immediately after birth heart rate will be evaluated by auscultation

Heart assessment (umbilical cord palpation)

Other

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

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

    Time frame: 1 minute

Secondary outcomes

  1. Time of the first breath

    Time frame: 20 minutes

  2. Time of regular breathing

    Time frame: 20 minutes

  3. Mortality rate

    Time frame: 1 month (during hospitalization)

  4. Number (%) of asphyxiated neonates

    Time frame: 5 min

  5. Age at discharge/death (days)

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

University Hospital Padova

Other

Collaborators

  • CUAMM Doctors with Africa, Padova, Italy
  • St. Luke Catholic Hospital, Wolisso, Ethiopia

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 26, 2019
Registry last updated
Oct 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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