The NeoBeat Efficacy Study for Newborns
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|ClinicalTrials.gov Identifier: NCT03849781|
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : May 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Newborn Resuscitation Heart Rate Monitoring||Device: NeoBeat with a visible display||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Enhanced Heart Rate Monitoring of Newborns After Birth and During Resuscitation|
|Actual Study Start Date :||March 8, 2019|
|Estimated Primary Completion Date :||July 1, 2022|
|Estimated Study Completion Date :||July 1, 2022|
Active Comparator: 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.
Device: 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.
No Intervention: 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.
- 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
- Change in time from birth to initiation of PPV [ Time Frame: first 15 minutes of life ]defined as seconds between birth and initiation of PPV
- Change in total duration of PPV [ Time Frame: first hour of life ]defined as seconds of PPV in total
- Change in time from birth to a stable HR ≥100 and 120 bpm [ Time Frame: first hour of life ]defined as HR ≥100 and 120 bpm for ≥ 60 seconds after discontinuing PPV
- Change in time for pulse oximeter saturation to reach stable values of ≥ 95% without oxygen supplementation [ Time Frame: first hour of life ]defined as seconds between birth to reach saturation values ≥ 95% without oxygen supplementation
- Adequate Vt delivered during PPV [ Time Frame: first hour of life ]defined as proportion of time of PPV with Vt ≥ 6 ml/kg
- Change in ventilation fraction [ Time Frame: first hour of life ]defined as cumulative number of seconds with PPV efforts excluding pauses
- Change in number of infants with Apgar score <7 at 5 and 10 minutes [ Time Frame: first 10 minutes of life ]Apgar score at 5 and 10 minutes
- Change in NICU admission rate after resuscitation [ Time Frame: first hour of life ]defined as percentage of newborns needing admission to the NICU after resuscitation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03849781
|Contact: Siren I Rettedal, PhD||+47 email@example.com|
|Contact: Hege Ersdal, PhDfirstname.lastname@example.org|
|Stavanger University Hospital||Recruiting|
|Stavanger, Rogaland, Norway, 4068|
|Contact: Siren I Rettedal, PhD +47 45235742 email@example.com|
|Contact: Hege L Ersdal, Associate Professor +47 99647822 firstname.lastname@example.org|
|Study Director:||Svein Skeie, MD PhD||Stavanger University Hosptial|