The NeoBeat Efficacy Study for Newborns

Study Overview
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Brief Summary
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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
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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.

Official Title
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Enhanced Heart Rate Monitoring of Newborns After Birth and During Resuscitation

Conditions
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Newborn Resuscitation, Heart Rate Monitoring

Intervention / Treatment
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* Device: NeoBeat with a visible display


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inborn, Gestational age ≥ 28 weeks, Multiples according to availability of equipment Exclusion Criteria: Congenital malformations that interfere with the intervention, Non-consent

Ages Eligible for Study
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Maximum Age: 60 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>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<br>* 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.<br>|
| No Intervention: Standard Care<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of cases with adherence to resuscitation guidelines in non-breathing newborns | Defined as initiation of PPV within on minute | First minute after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in time from birth to initiation of PPV | defined as seconds between birth and initiation of PPV | first 15 minutes of life | 
| Change in total duration of PPV | defined as seconds of PPV in total | 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 | 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 | first hour of life | 
| Adequate Vt delivered during PPV | defined as proportion of time of PPV with Vt ≥ 6 ml/kg | first hour of life | 
| Change in ventilation fraction | defined as cumulative number of seconds with PPV efforts excluding pauses | 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 | first 10 minutes of life | 
| Change in NICU admission rate after resuscitation | defined as percentage of newborns needing admission to the NICU after resuscitation | first hour of life |