Newborn ResuscitationNCT03849781
The NeoBeat Efficacy Study for Newborns
A study testing NeoBeat with a visible display in people with Newborn Resuscitation and Heart Rate Monitoring, run by Helse Stavanger HF at 1 site in Norway.
Trial summary
In a multicenter randomized controlled trial the investigators will evaluate the efficacy of the novel heart rate meter NeoBeat on ventilation performance and short-term outcomes compared to standard care in newborns in need of positive pressure ventilation to initiate spontaneous breathing after birth. Read more about this study
- Who is it for?
- Ages Up to 60 minutesHealthy volunteers can take part
- Conditions the study is for
- Newborn Resuscitation, Heart Rate Monitoring
- What is being tested?
- NeoBeat with a visible display
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteNorway
- Study dates
- 8 Mar 2019to 1 Jul 2022
- 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 60 minutes
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Inborn, Gestational age ≥ 28 weeks, Multiples according to availability of equipment
Who cannot join
- Congenital malformations that interfere with the intervention, Non-consent
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Stavanger University Hospital
Stavanger, Rogaland, 4068
Siren I Rettedal, PhD, +47 45235742, siren.irene.rettedal@sus.no
Hege L Ersdal, Associate Professor, +47 99647822, hege.ersdal@safer.net
About this study
Official title: Enhanced Heart Rate Monitoring of Newborns After Birth and During Resuscitation
In a multicenter randomized controlled trial the investigators will evaluate the efficacy of the novel heart rate meter NeoBeat on ventilation performance and short-term outcomes compared to standard care in newborns in need of positive pressure ventilation to initiate spontaneous breathing after birth.
Read the detailed description
Heart rate assessment immediately after birth in newborn infants is the most important clinical indicator to evaluate the status of a newborn, and critical to the correct guidance of resuscitation efforts.
One of the knowledge gaps identified by the International Liason Committee on Resuscitation (ILCOR) is how best to assess ventilation during newborn resuscitation, and improved technology for rapid application of ECG.
Laerdal Medical has developed a novel heart rate meter, NeoBeat, implementing ECG dry-electrodes in a snug-fit abdomen-shaped buckle for for rapid application on the newborn.
In a multicenter randomized controlled trial the investigators will study the efficacy of NeoBeat on ventilation performance and short-term outcomes compared to standard care in newborns in need of positive pressure ventilation to initiate spontaneous respiration after birth.
- Conditions
- Newborn Resuscitation, Heart Rate Monitoring
- Being tested
- NeoBeat with a visible display
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoBeat with a visible displayDevice
NeoBeat (Laerdal Medical) is a CE approved novel heart rate meter, able to detect heart rate in newborns within seconds of birth. The NeoBeat uses ECG dry-electrodes in a snug-fit abdomen-shaped buckle for rapid application around the newborn's abdomen or thorax. It allows healthcare providers to reliably assess heart rate of the newborn immediately after birth and continuously during resuscitation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | NeoBeat will be placed on all newborns immediately after birth to assess the heartrate for at least 5 minutes, or longer if the newborn needs resuscitation. Intervention subjects will have a visible display of the heart rate on the NeoBeat, to guide healthcare providers in further management of the newborn. Receives: Device: NeoBeat with a visible display |
| Standard Care | No intervention | NeoBeat will be placed on the newborn to collect information on heart rate, but heart rate is not displayed to the healthcare providers. If the newborn is in need of resuscitation to initiate spontaneous respiration, the baby will be transferred to the resuscitation bay. According to recommendations the heart rate should be assessed and positive pressure ventilation initiated within one minute of life. Standard care is to assess heart rate by conventional ECG and/or pulse oximetry, alternatively auscultation of the heart. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of cases with adherence to resuscitation guidelines in non-breathing newborns
Defined as initiation of PPV within on minute
Measured: First minute after birth
Secondary outcomes (8)
Change in time from birth to initiation of PPV
defined as seconds between birth and initiation of PPV
Measured: first 15 minutes of life
Change in total duration of PPV
defined as seconds of PPV in total
Measured: first hour of life
Change in time from birth to a stable HR ≥100 and 120 bpm
defined as HR ≥100 and 120 bpm for ≥ 60 seconds after discontinuing PPV
Measured: first hour of life
Change in time for pulse oximeter saturation to reach stable values of ≥ 95% without oxygen supplementation
defined as seconds between birth to reach saturation values ≥ 95% without oxygen supplementation
Measured: first hour of life
Adequate Vt delivered during PPV
defined as proportion of time of PPV with Vt ≥ 6 ml/kg
Measured: first hour of life
Change in ventilation fraction
defined as cumulative number of seconds with PPV efforts excluding pauses
Measured: first hour of life
Change in number of infants with Apgar score <7 at 5 and 10 minutes
Apgar score at 5 and 10 minutes
Measured: first 10 minutes of life
Change in NICU admission rate after resuscitation
defined as percentage of newborns needing admission to the NICU after resuscitation
Measured: first hour of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start8 Mar 2019
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Newborn ResuscitationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- Sykehuset Østfold, Laerdal Medical
- Responsible party
- Sponsor
- Investigators
- Svein Skeie, MD PhD, Study director, Stavanger University Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849781
- Sponsor's protocol ID
- SUS2019SIR
- Status last verified
- Jan 2019
- First submitted
- 30 Jan 2019
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoven ET, Meling Roine FM, Buskov F, Brunner S, Haynes J, Ersdal H, Rettedal S. Selection bias introduced in a randomized clinical trial due to employee instigated deletion of newborn resuscitation videos. Resuscitation. 2026 Sep 1;227:111288. doi: 10.1016/j.resuscitation.2026.111288. Online ahead of print.
PubMed 42679886Rettedal S, Buskov F, Kibsgaard A, Kvaloy JT, Hooper S, Davis P, Ersdal HL. The relationship between umbilical arterial pH, newborn heart rate and ventilation at birth - a prospective observational study. Resuscitation. 2026 Jul 7:111197. doi: 10.1016/j.resuscitation.2026.111197. Online ahead of print.
PubMed 42413757Rettedal S, Kibsgaard A, Kvaloy JT, Eilevstjonn J, Ersdal HL. Prevalence of bradycardia in 4876 newborns in the first minute after birth and association with positive pressure ventilation: a population-based cross-sectional study. Arch Dis Child Fetal Neonatal Ed. 2024 Jun 19;109(4):371-377. doi: 10.1136/archdischild-2023-325878.
PubMed 37940377Rettedal S, Kibsgaard A, Eilevstjonn J, Kvaloy JT, Bjorland PA, Markhus Pike H, Haynes J, Tysland TB, Stordal K, Holte K, Davis PG, Ersdal HL. Impact of immediate and continuous heart rate feedback by dry electrode ECG on time to initiation of ventilation after birth: protocol for a randomised controlled trial. BMJ Open. 2022 Sep 7;12(9):e061839. doi: 10.1136/bmjopen-2022-061839.
PubMed 36691167
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Heart Rate Monitoring of Newborns After Birth and During Resuscitation
- ClinicalTrials.gov ID
- NCT03849781
- Acronym / sponsor ID
- SUS2019SIR
- Conditions
- Newborn Resuscitation, Heart Rate Monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- Sykehuset Østfold, Laerdal Medical
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 21 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.
In a multicenter randomized controlled trial the investigators will evaluate the efficacy of the novel heart rate meter NeoBeat on ventilation performance and short-term outcomes compared to standard care in newborns in need of positive pressure ventilation to initiate spontaneous breathing after birth.
Detailed description
Heart rate assessment immediately after birth in newborn infants is the most important clinical indicator to evaluate the status of a newborn, and critical to the correct guidance of resuscitation efforts.
One of the knowledge gaps identified by the International Liason Committee on Resuscitation (ILCOR) is how best to assess ventilation during newborn resuscitation, and improved technology for rapid application of ECG.
Laerdal Medical has developed a novel heart rate meter, NeoBeat, implementing ECG dry-electrodes in a snug-fit abdomen-shaped buckle for for rapid application on the newborn.
In a multicenter randomized controlled trial the investigators will study the efficacy of NeoBeat on ventilation performance and short-term outcomes compared to standard care in newborns in need of positive pressure ventilation to initiate spontaneous respiration after birth.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Device: NeoBeat with a visible displayNeoBeat will be placed on all newborns immediately after birth to assess the heartrate for at least 5 minutes, or longer if the newborn needs resuscitation. Intervention subjects will have a visible display of the heart rate on the NeoBeat, to guide healthcare providers in further management of the newborn. |
| Standard Care | No intervention | –NeoBeat will be placed on the newborn to collect information on heart rate, but heart rate is not displayed to the healthcare providers. If the newborn is in need of resuscitation to initiate spontaneous respiration, the baby will be transferred to the resuscitation bay. According to recommendations the heart rate should be assessed and positive pressure ventilation initiated within one minute of life. Standard care is to assess heart rate by conventional ECG and/or pulse oximetry, alternatively auscultation of the heart. |
Who may qualify
- Ages
- Up to 60 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Inborn, Gestational age ≥ 28 weeks, Multiples according to availability of equipment
Key exclusion criteria (1 listed)
- Congenital malformations that interfere with the intervention, Non-consent
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 |
|---|---|---|
| NeoBeat with a visible displayNeoBeat (Laerdal Medical) is a CE approved novel heart rate meter, able to detect heart rate in newborns within seconds of birth. The NeoBeat uses ECG dry-electrodes in a snug-fit abdomen-shaped buckle for rapid application around the newborn's abdomen or thorax. It allows healthcare providers to reliably assess heart rate of the newborn immediately after birth and continuously during resuscitation. | Device | Intervention |
Primary outcome
Proportion of cases with adherence to resuscitation guidelines in non-breathing newborns
Time frame: First minute after birth
Defined as initiation of PPV within on minute
8 secondary outcomes
Change in time from birth to initiation of PPV
Time frame: first 15 minutes of life
Change in total duration of PPV
Time frame: first hour of life
Change in time from birth to a stable HR ≥100 and 120 bpm
Time frame: first hour of life
Change in time for pulse oximeter saturation to reach stable values of ≥ 95% without oxygen supplementation
Time frame: first hour of life
Adequate Vt delivered during PPV
Time frame: first hour of life
Change in ventilation fraction
Time frame: first hour of life
Change in number of infants with Apgar score <7 at 5 and 10 minutes
Time frame: first 10 minutes of life
Change in NICU admission rate after resuscitation
Time frame: first hour of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Derived from this study: PubMed 42679886Hoven ET, Meling Roine FM, Buskov F, Brunner S, Haynes J, Ersdal H, Rettedal S. Selection bias introduced in a randomized clinical trial due to employee instigated deletion of newborn resuscitation videos. Resuscitation. 2026 Sep 1;227:111288. doi: 10.1016/j.resuscitation.2026.111288. Online ahead of print.
- Derived from this study: PubMed 42413757Rettedal S, Buskov F, Kibsgaard A, Kvaloy JT, Hooper S, Davis P, Ersdal HL. The relationship between umbilical arterial pH, newborn heart rate and ventilation at birth - a prospective observational study. Resuscitation. 2026 Jul 7:111197. doi: 10.1016/j.resuscitation.2026.111197. Online ahead of print.
- Derived from this study: PubMed 37940377Rettedal S, Kibsgaard A, Kvaloy JT, Eilevstjonn J, Ersdal HL. Prevalence of bradycardia in 4876 newborns in the first minute after birth and association with positive pressure ventilation: a population-based cross-sectional study. Arch Dis Child Fetal Neonatal Ed. 2024 Jun 19;109(4):371-377. doi: 10.1136/archdischild-2023-325878.
- Derived from this study: PubMed 36691167Rettedal S, Kibsgaard A, Eilevstjonn J, Kvaloy JT, Bjorland PA, Markhus Pike H, Haynes J, Tysland TB, Stordal K, Holte K, Davis PG, Ersdal HL. Impact of immediate and continuous heart rate feedback by dry electrode ECG on time to initiation of ventilation after birth: protocol for a randomised controlled trial. BMJ Open. 2022 Sep 7;12(9):e061839. doi: 10.1136/bmjopen-2022-061839.
- 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.
Svein Skeie, MD PhD study director
Stavanger University Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeoBeat with a visible display in people with Newborn Resuscitation and Heart Rate Monitoring, run by Helse Stavanger HF at 1 site in Norway.
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: status not confirmed, as of the sponsor's last update on 15 May 2019. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Siren I Rettedal, PhD (+47 45235742, siren.irene.rettedal@sus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of cases with adherence to resuscitation guidelines in non-breathing newborns (time frame: First minute after 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 NCT03849781, which also lists 4 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 15 May 2019.