NCT03849781|Unknown
The NeoBeat Efficacy Study for Newborns
Enhanced Heart Rate Monitoring of Newborns After Birth and During Resuscitation
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Enhanced Heart Rate Monitoring of Newborns After Birth and During Resuscitation
Sponsor study identifier
interventional
500
1 country
1
Study Start
March 8, 2019
Actual (reported)Primary Completion
July 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 30, 2019
Actual (reported)February 21, 2019
Actual (reported)March 8, 2019
Actual (reported)July 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Proportion of cases with adherence to resuscitation guidelines in non-breathing newborns
Defined as initiation of PPV within on minute
First minute after birth
Change in time from birth to initiation of PPV
first 15 minutes of life
Change in total duration of PPV
first hour of life
Change in time from birth to a stable HR ≥100 and 120 bpm
first hour of life
Change in time for pulse oximeter saturation to reach stable values of ≥ 95% without oxygen supplementation
first hour of life
Adequate Vt delivered during PPV
first hour of life
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 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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Stavanger University Hospital
Stavanger, Rogaland, 4068, Norway
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.
Rettedal 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.
Svein Skeie, MD PhD
Stavanger University Hosptial
First Submitted
January 30, 2019
First Posted
February 21, 2019
Study Start
March 8, 2019
Actual (reported)Primary Completion
July 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Wearable Technology for Hospital Inpatients
Contact the study team to confirm eligibility.
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.
Study Completion
July 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 15, 2019
Record last verified: 2019-01
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Source: ClinicalTrials.gov.
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