Asphyxia NeonatorumNCT03913533
Heart Rate Assessment at Birth Comparing Stethoscope Versus Tap-based Application
A study testing Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method and Heart rate assessment using Tap-based smartphone application in people with Asphyxia Neonatorum and Birth Asphyxia, run by University of Alberta at 1 site in Canada.
Trial summary
Some newborn babies have difficulty breathing at birth and need help. When babies need help with breathing the clinical team, the team measures heart rate using a stethoscope to check its heart rate and figure out what kind of help they will need. Read more about this study
- Who is it for?
- Ages Up to 5 minutes
- Conditions the study is for
- Asphyxia Neonatorum, Birth Asphyxia
- What is being tested?
- Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method and Heart rate assessment using Tap-based smartphone application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 16 Dec 2019to 31 Oct 2021
- 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 5 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All newborn infants delivered in the Royal Alexandra Hospital (RAH) 22+0-41+6 weeks gestation.
Who cannot join
- Infants will be excluded if parents refused to consent to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Standard 6-sec Method Versus Tap-based Application Method to Assess Heart Rate at Birth - a Randomized Controlled Trial
Some newborn babies have difficulty breathing at birth and need help. When babies need help with breathing the clinical team, the team measures heart rate using a stethoscope to check its heart rate and figure out what kind of help they will need. If the heart rate is too low, the clinical team will begin to inflate the baby's lung. Knowing the baby's heart rate quickly is important but the stethoscope is inaccurate, and might delay start of resuscitation. Using a smartphone app that uses screen tapping with a stethoscope could allow heart rate to be measured much faster compared to the stethoscope and allow the clinical team to support the baby's needs better immediately after birth.
Read the detailed description
Purpose
Nearly 10% of all infants born worldwide require respiratory support at birth and birth asphyxia remains one of the leading causes of infant morbidity and mortality. Neonatal resuscitation is the most effective strategy to deal with this condition. Moreover, an infant's heart rate (HR) is the most significant clinical parameter used to assess the need for and response to neonatal resuscitation. Currently, a newborn's HR is determined by auscultating or palpating of the umbilical cord. Although auscultation is more precise compared to palpation, both methods are inaccurate and tend to underestimate HR. The current resuscitation guidelines also recommend using electrocardiogram (ECG) and pulse oximetry, which allow for continuous monitoring, however are slow to apply and detect HR compared to stethoscopes. During neonatal resuscitation, an infant's HR is necessary to initiate resuscitation and to monitor the effectiveness of each intervention and therefore it becomes essential to accurately and quickly assess an infant's HR during this process. If HR is detected slowly or inaccurately, there is an increased risk that necessary interventions are not started or that certain interventions are prolonged, which could lead to increased morbidity and mortality of the infants. The recent advances in technology, namely the development of a smartphone tap application for HR assessment is promising as a novel tool for quick and accurate HR detection during neonatal resuscitation.
Hypothesis
The use of a tap-based smartphone application will be faster and more accurate when compared to standard auscultation with the 6-sec method to assess HR.
Justification
Simulation studies have shown that it is feasible to measure HR using a tap-based application. Moreover, the investigator's group has recently shown its reliability in an animal model of asphyxia-induced neonatal swine. The investigator showed its accuracy compared to the experimental gold standard carotid blood flow-derived HR assessments and report a median time of 3 sec for assessment, which is less than the current recommended time for auscultation. However, no study has been performed in the delivery room in newborn babies at birth. Therefore, the investigator aim to compare the tap-based application to the current 6-sec standard approach to assess HR during neonatal resuscitation in the delivery room. Ehe investigator anticipate this study will allow us to determine the most reliable approach for initial assessment to reduce neonatal morbidity and mortality outcomes.
Objectives
To examine (i) accuracy and (ii) speed to assess HR using auscultation with a tap-based application during neonatal resuscitation.
Research Method/Procedures
The proposed study is a randomized controlled trial comparing two different approaches to accurately assess HR. The investigator will compare the routinely used Neonatal Resuscitation Program 6-sec method with a stethoscope using two different methods of auscultation [6-sec method and tap-based method (NeoTapLS, Tap4Life, Stockholm, Sweden)] to accurately assess HR immediately after birth. The investigator aim to collect the data over a period of 12 months.
Two investigators in addition to the clinical team will attend the delivery of newborn infants. Immediately after birth the infant will be placed on a resuscitation trolley where a pulse oximeter will be attached to the right hand. At the same time three ECG leads will be placed on the infant's chest. Simultaneously the stethoscope will be placed by one of the investigators on the infants' chest to obtain the HR . In the alternative setup, stethoscope will be used in combination with the tap-based application.
In both setups, the time needed to display a HR will be recorded for all devices. All infants will have routine HR measured using ECG, which will be used as comparison for accuracy
- Conditions
- Asphyxia Neonatorum, Birth Asphyxia
- Being tested
- Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method, Heart rate assessment using Tap-based smartphone application
- Keywords
- Newborn, Heart rate assessment, Delivery Room
- Medical subject headings
- Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment methodDevice
Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method At birth, the clinical team will place the stethoscope on the infant chest and calculate heart rate by listening to the heart beat for 6-sec and then compute the heart rate of the newborn infant.
Heart rate assessment using Tap-based smartphone applicationDevice
At birth, the clinical team will place the stethoscope on the infant chest and calculate heart rate using a Tap-based smartphone application by tapping the screen for 3 beats at that time a heart rate will be displayed.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method At birth, the clinical team will place the stethoscope on the infant chest and calculate heart rate by listening to the heart beat for 6-sec and then compute the heart rate of the newborn infant. Receives: Device: Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method |
| Intervention group | Experimental | Heart rate assessment using Tap-based smartphone application At birth, the clinical team will place the stethoscope on the infant chest and calculate heart rate using a Tap-based smartphone application by tapping the screen for 3 beats at that time a heart rate will be displayed. Receives: Device: Heart rate assessment using Tap-based smartphone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to obtain Heart rate
Time to obtain Heart rate form birth
Measured: within the first 60 seconds form birth
Secondary outcomes (1)
Accuracy of heart rate assessment using either technique
Accuracy of heart rate assessment using tap-based application or 6-sec method
Measured: within the first 60 seconds form birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start16 Dec 2019
- Primary completion30 Apr 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Why it stopped: No funding obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Asphyxia NeonatorumStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georg Schmolzer, MD, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913533
- Sponsor's protocol ID
- Pro00089994
- Status last verified
- Sep 2021
- First submitted
- 22 Mar 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: requests can be made to the PI
Publications
Saugstad OD, Ramji S, Rootwelt T, Vento M. Response to resuscitation of the newborn: early prognostic variables. Acta Paediatr. 2005 Jul;94(7):890-5. doi: 10.1111/j.1651-2227.2005.tb02007.x.
PubMed 16188811Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin JG. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S543-60. doi: 10.1161/CIR.0000000000000267. No abstract available.
PubMed 26473001Duryea EL, Nelson DB, Wyckoff MH, Grant EN, Tao W, Sadana N, Chalak LF, McIntire DD, Leveno KJ. The impact of ambient operating room temperature on neonatal and maternal hypothermia and associated morbidities: a randomized controlled trial. Am J Obstet Gynecol. 2016 Apr;214(4):505.e1-505.e7. doi: 10.1016/j.ajog.2016.01.190. Epub 2016 Feb 10.
PubMed 26874298Kamlin CO, O'Donnell CP, Everest NJ, Davis PG, Morley CJ. Accuracy of clinical assessment of infant heart rate in the delivery room. Resuscitation. 2006 Dec;71(3):319-21. doi: 10.1016/j.resuscitation.2006.04.015. Epub 2006 Sep 20.
PubMed 16989935Kamlin CO, Dawson JA, O'Donnell CP, Morley CJ, Donath SM, Sekhon J, Davis PG. Accuracy of pulse oximetry measurement of heart rate of newborn infants in the delivery room. J Pediatr. 2008 Jun;152(6):756-60. doi: 10.1016/j.jpeds.2008.01.002. Epub 2008 Mar 6.
PubMed 18492509Kopotic RJ, Lindner W. Assessing high-risk infants in the delivery room with pulse oximetry. Anesth Analg. 2002 Jan;94(1 Suppl):S31-6.
PubMed 11900034Luong DH, Cheung PY, O'Reilly M, Lee TF, Schmolzer GM. Electrocardiography vs. Auscultation to Assess Heart Rate During Cardiac Arrest With Pulseless Electrical Activity in Newborn Infants. Front Pediatr. 2018 Nov 27;6:366. doi: 10.3389/fped.2018.00366. eCollection 2018.
PubMed 30538976Patel S, Cheung PY, Solevag AL, Barrington KJ, Kamlin COF, Davis PG, Schmolzer GM. Pulseless electrical activity: a misdiagnosed entity during asphyxia in newborn infants? Arch Dis Child Fetal Neonatal Ed. 2019 Mar;104(2):F215-F217. doi: 10.1136/archdischild-2018-314907. Epub 2018 Jun 12.
PubMed 29895572Owen CJ, Wyllie JP. Determination of heart rate in the baby at birth. Resuscitation. 2004 Feb;60(2):213-7. doi: 10.1016/j.resuscitation.2003.10.002.
PubMed 15036740Voogdt KG, Morrison AC, Wood FE, van Elburg RM, Wyllie JP. A randomised, simulated study assessing auscultation of heart rate at birth. Resuscitation. 2010 Aug;81(8):1000-3. doi: 10.1016/j.resuscitation.2010.03.021. Epub 2010 May 18.
PubMed 20483522Binotti M, Cavallin F, Ingrassia PL, Pejovic NJ, Monzani A, Genoni G, Trevisanuto D. Heart rate assessment using NeoTapAdvancedSupport: a simulation study. Arch Dis Child Fetal Neonatal Ed. 2019 Jul;104(4):F440-F442. doi: 10.1136/archdischild-2018-315408. Epub 2018 Sep 27.
PubMed 30262463
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard 6-sec Method Versus Tap-based Application Method to Assess Heart Rate at Birth - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03913533
- Acronym / sponsor ID
- Pro00089994
- Conditions
- Asphyxia Neonatorum, Birth Asphyxia
- Keywords
- Newborn, Heart rate assessment, Delivery Room
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding obtained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 12 Apr 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.
Some newborn babies have difficulty breathing at birth and need help. When babies need help with breathing the clinical team, the team measures heart rate using a stethoscope to check its heart rate and figure out what kind of help they will need. If the heart rate is too low, the clinical team will begin to inflate the baby's lung. Knowing the baby's heart rate quickly is important but the stethoscope is inaccurate, and might delay start of resuscitation. Using a smartphone app that uses screen tapping with a stethoscope could allow heart rate to be measured much faster compared to the stethoscope and allow the clinical team to support the baby's needs better immediately after birth.
Detailed description
Purpose
Nearly 10% of all infants born worldwide require respiratory support at birth and birth asphyxia remains one of the leading causes of infant morbidity and mortality. Neonatal resuscitation is the most effective strategy to deal with this condition. Moreover, an infant's heart rate (HR) is the most significant clinical parameter used to assess the need for and response to neonatal resuscitation. Currently, a newborn's HR is determined by auscultating or palpating of the umbilical cord. Although auscultation is more precise compared to palpation, both methods are inaccurate and tend to underestimate HR. The current resuscitation guidelines also recommend using electrocardiogram (ECG) and pulse oximetry, which allow for continuous monitoring, however are slow to apply and detect HR compared to stethoscopes. During neonatal resuscitation, an infant's HR is necessary to initiate resuscitation and to monitor the effectiveness of each intervention and therefore it becomes essential to accurately and quickly assess an infant's HR during this process. If HR is detected slowly or inaccurately, there is an increased risk that necessary interventions are not started or that certain interventions are prolonged, which could lead to increased morbidity and mortality of the infants. The recent advances in technology, namely the development of a smartphone tap application for HR assessment is promising as a novel tool for quick and accurate HR detection during neonatal resuscitation.
Hypothesis
The use of a tap-based smartphone application will be faster and more accurate when compared to standard auscultation with the 6-sec method to assess HR.
Justification
Simulation studies have shown that it is feasible to measure HR using a tap-based application. Moreover, the investigator's group has recently shown its reliability in an animal model of asphyxia-induced neonatal swine. The investigator showed its accuracy compared to the experimental gold standard carotid blood flow-derived HR assessments and report a median time of 3 sec for assessment, which is less than the current recommended time for auscultation. However, no study has been performed in the delivery room in newborn babies at birth. Therefore, the investigator aim to compare the tap-based application to the current 6-sec standard approach to assess HR during neonatal resuscitation in the delivery room. Ehe investigator anticipate this study will allow us to determine the most reliable approach for initial assessment to reduce neonatal morbidity and mortality outcomes.
Objectives
To examine (i) accuracy and (ii) speed to assess HR using auscultation with a tap-based application during neonatal resuscitation.
Research Method/Procedures
The proposed study is a randomized controlled trial comparing two different approaches to accurately assess HR. The investigator will compare the routinely used Neonatal Resuscitation Program 6-sec method with a stethoscope using two different methods of auscultation [6-sec method and tap-based method (NeoTapLS, Tap4Life, Stockholm, Sweden)] to accurately assess HR immediately after birth. The investigator aim to collect the data over a period of 12 months.
Two investigators in addition to the clinical team will attend the delivery of newborn infants. Immediately after birth the infant will be placed on a resuscitation trolley where a pulse oximeter will be attached to the right hand. At the same time three ECG leads will be placed on the infant's chest. Simultaneously the stethoscope will be placed by one of the investigators on the infants' chest to obtain the HR . In the alternative setup, stethoscope will be used in combination with the tap-based application.
In both setups, the time needed to display a HR will be recorded for all devices. All infants will have routine HR measured using ECG, which will be used as comparison for accuracy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment methodHeart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method At birth, the clinical team will place the stethoscope on the infant chest and calculate heart rate by listening to the heart beat for 6-sec and then compute the heart rate of the newborn infant. |
| Intervention group | Experimental | Device: Heart rate assessment using Tap-based smartphone applicationHeart rate assessment using Tap-based smartphone application At birth, the clinical team will place the stethoscope on the infant chest and calculate heart rate using a Tap-based smartphone application by tapping the screen for 3 beats at that time a heart rate will be displayed. |
Who may qualify
- Ages
- Up to 5 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All newborn infants delivered in the Royal Alexandra Hospital (RAH) 22+0-41+6 weeks gestation.
Key exclusion criteria (1 listed)
- Infants will be excluded if parents refused to consent 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 using the Neonatal Resuscitation Program 6-sec assessment methodHeart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method At birth, the clinical team will place the stethoscope on the infant chest and calculate heart rate by listening to the heart beat for 6-sec and then compute the heart rate of the newborn infant. | Device | Control group |
| Heart rate assessment using Tap-based smartphone applicationAt birth, the clinical team will place the stethoscope on the infant chest and calculate heart rate using a Tap-based smartphone application by tapping the screen for 3 beats at that time a heart rate will be displayed. | Device | Intervention group |
Primary outcome
Time to obtain Heart rate
Time frame: within the first 60 seconds form birth
Time to obtain Heart rate form birth
1 secondary outcome
Accuracy of heart rate assessment using either technique
Time frame: within the first 60 seconds form birth
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 16188811Saugstad OD, Ramji S, Rootwelt T, Vento M. Response to resuscitation of the newborn: early prognostic variables. Acta Paediatr. 2005 Jul;94(7):890-5. doi: 10.1111/j.1651-2227.2005.tb02007.x.
- Results publication: PubMed 26473001Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin JG. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S543-60. doi: 10.1161/CIR.0000000000000267. No abstract available.
- Results publication: PubMed 26874298Duryea EL, Nelson DB, Wyckoff MH, Grant EN, Tao W, Sadana N, Chalak LF, McIntire DD, Leveno KJ. The impact of ambient operating room temperature on neonatal and maternal hypothermia and associated morbidities: a randomized controlled trial. Am J Obstet Gynecol. 2016 Apr;214(4):505.e1-505.e7. doi: 10.1016/j.ajog.2016.01.190. Epub 2016 Feb 10.
- Results publication: PubMed 16989935Kamlin CO, O'Donnell CP, Everest NJ, Davis PG, Morley CJ. Accuracy of clinical assessment of infant heart rate in the delivery room. Resuscitation. 2006 Dec;71(3):319-21. doi: 10.1016/j.resuscitation.2006.04.015. Epub 2006 Sep 20.
- Results publication: PubMed 18492509Kamlin CO, Dawson JA, O'Donnell CP, Morley CJ, Donath SM, Sekhon J, Davis PG. Accuracy of pulse oximetry measurement of heart rate of newborn infants in the delivery room. J Pediatr. 2008 Jun;152(6):756-60. doi: 10.1016/j.jpeds.2008.01.002. Epub 2008 Mar 6.
- Results publication: PubMed 11900034Kopotic RJ, Lindner W. Assessing high-risk infants in the delivery room with pulse oximetry. Anesth Analg. 2002 Jan;94(1 Suppl):S31-6.
- Results publication: PubMed 30538976Luong DH, Cheung PY, O'Reilly M, Lee TF, Schmolzer GM. Electrocardiography vs. Auscultation to Assess Heart Rate During Cardiac Arrest With Pulseless Electrical Activity in Newborn Infants. Front Pediatr. 2018 Nov 27;6:366. doi: 10.3389/fped.2018.00366. eCollection 2018.
- Results publication: PubMed 29895572Patel S, Cheung PY, Solevag AL, Barrington KJ, Kamlin COF, Davis PG, Schmolzer GM. Pulseless electrical activity: a misdiagnosed entity during asphyxia in newborn infants? Arch Dis Child Fetal Neonatal Ed. 2019 Mar;104(2):F215-F217. doi: 10.1136/archdischild-2018-314907. Epub 2018 Jun 12.
- Results publication: PubMed 15036740Owen CJ, Wyllie JP. Determination of heart rate in the baby at birth. Resuscitation. 2004 Feb;60(2):213-7. doi: 10.1016/j.resuscitation.2003.10.002.
- Results publication: PubMed 20483522Voogdt KG, Morrison AC, Wood FE, van Elburg RM, Wyllie JP. A randomised, simulated study assessing auscultation of heart rate at birth. Resuscitation. 2010 Aug;81(8):1000-3. doi: 10.1016/j.resuscitation.2010.03.021. Epub 2010 May 18.
- Results publication: PubMed 30262463Binotti M, Cavallin F, Ingrassia PL, Pejovic NJ, Monzani A, Genoni G, Trevisanuto D. Heart rate assessment using NeoTapAdvancedSupport: a simulation study. Arch Dis Child Fetal Neonatal Ed. 2019 Jul;104(4):F440-F442. doi: 10.1136/archdischild-2018-315408. Epub 2018 Sep 27.
- Individual participant dataSharing planned: Yes. requests can be made to the PI
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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.
Georg Schmolzer, MD, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method and Heart rate assessment using Tap-based smartphone application in people with Asphyxia Neonatorum and Birth Asphyxia, run by University of Alberta at 1 site in Canada.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Time to obtain Heart rate (time frame: within the first 60 seconds form birth). 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 NCT03913533, which also lists 11 linked publications.
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 19 Sep 2024.