NCT03849781

The NeoBeat Efficacy Study for Newborns

Enhanced Heart Rate Monitoring of Newborns After Birth and During Resuscitation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Helse Stavanger HF · Other Government
• Sex: All
• Age: 60 Minutes
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Newborn Resuscitation
• Heart Rate Monitoring

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-03-08
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2019-02-21
• Last updated: 2019-05-15

Locations

1 site across 1 country: Norway