Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
500 participants
INTERVENTIONAL
2019-03-08
2022-07-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention
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.
NeoBeat with a visible display
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.
Standard Care
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.
No interventions assigned to this group
Interventions
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NeoBeat with a visible display
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
60 Minutes
ALL
Yes
Sponsors
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Sykehuset Østfold
UNKNOWN
Laerdal Medical
INDUSTRY
Helse Stavanger HF
OTHER_GOV
Responsible Party
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Principal Investigators
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Svein Skeie, MD PhD
Role: STUDY_DIRECTOR
Stavanger University Hosptial
Locations
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Stavanger University Hospital
Stavanger, Rogaland, Norway
Countries
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Central Contacts
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Facility Contacts
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References
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Rettedal 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.
Rettedal 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.
Other Identifiers
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SUS2019SIR
Identifier Type: -
Identifier Source: org_study_id
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