The NeoBeat Efficacy Study for Newborns

Helse Stavanger HF

Status: Unknown

Conditions: Newborn Resuscitation; Heart Rate Monitoring

Treatments: Device: NeoBeat with a visible display

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03849781

SUS2019SIR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: Under 60 minutes old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Inborn, Gestational age ≥ 28 weeks, Multiples according to availability of equipment

Exclusion criteria

Congenital malformations that interfere with the intervention, Non-consent

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Intervention

Active Comparator group

Description:

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.

Treatment:

Device: NeoBeat with a visible display

Standard Care

No Intervention group

Description:

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.