Perinatal AsphyxiaNCT03854435
Determination of Heart Rate in Infants Needing Resuscitation at Birth
A study testing Heart rate assessment (stethoscope) and Heart assessment (umbilical cord palpation) in people with Perinatal Asphyxia, run by University Hospital Padova at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 30 days
- Conditions the study is for
- Perinatal Asphyxia
- What is being tested?
- Heart rate assessment (stethoscope) and Heart assessment (umbilical cord palpation)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Feb 2019to 2 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Major congenital malformations;
- Parental refusal to participate to the study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
Read more
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
- Being tested
- Heart rate assessment (stethoscope), Heart assessment (umbilical cord palpation)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Heart assessment (umbilical cord palpation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 minute
Secondary outcomes (5)
Time of the first breath
Measured: 20 minutes
Time of regular breathing
Measured: 20 minutes
Mortality rate
Measured: 1 month (during hospitalization)
Number (%) of asphyxiated neonates
Measured: 5 min
Age at discharge/death (days)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start25 Feb 2019
- Primary completion2 Apr 2019
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perinatal AsphyxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Padova
- Sponsor type
- University, hospital or other
- Collaborators
- CUAMM Doctors with Africa, Padova, Italy, St. Luke Catholic Hospital, Wolisso, Ethiopia
- Responsible party
- Principal investigator, Daniele Trevisanuto, University Hospital Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854435
- Sponsor's protocol ID
- University of Padova
- Status last verified
- Oct 2019
- First submitted
- 29 Jan 2019
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32222255
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Heart Rate in Infants Needing Resuscitation at Birth
- ClinicalTrials.gov ID
- NCT03854435
- Acronym / sponsor ID
- University of Padova
- Conditions
- Perinatal Asphyxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital PadovaUniversity, hospital or other
- Collaborators
- CUAMM Doctors with Africa, Padova, Italy, St. Luke Catholic Hospital, Wolisso, Ethiopia
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 2 Apr 2019 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart rate assessed by using a stethoscope (auscultation) | Experimental | Other: 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 | Active comparator | Other: Heart assessment (umbilical cord palpation)Heart rate will be assessed by palpation of the umbilical in newborn infants immediately after birth |
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Major congenital malformations;
- Parental refusal to participate to the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart rate assessment (stethoscope)Immediately after birth heart rate will be evaluated by auscultation | Other | Heart rate assessed by using a stethoscope (auscultation) |
| Heart assessment (umbilical cord palpation)Immediately after birth heart rate will be evaluated by palpation of the umbilical cord | Other | Heart rate assessed by palpation of the umbilical cord |
Primary outcome
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
5 secondary outcomes
Time of the first breath
Time frame: 20 minutes
Time of regular breathing
Time frame: 20 minutes
Mortality rate
Time frame: 1 month (during hospitalization)
Number (%) of asphyxiated neonates
Time frame: 5 min
Age at discharge/death (days)
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
- Derived from this study: PubMed 32222255Cavallin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart rate assessment (stethoscope) and Heart assessment (umbilical cord palpation) in people with Perinatal Asphyxia, run by University Hospital Padova at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ethiopia, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03854435, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2019.