The NeoBeat Efficacy Study for Newborns

Heart Rate Monitoring Clinical Trial

Official title:

Enhanced Heart Rate Monitoring of Newborns After Birth and During Resuscitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03849781
• Other study ID #: SUS2019SIR
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2019
• Est. completion date: July 1, 2022

Study information

• Verified date: January 2019
• Source: Helse Stavanger HF
• Contact: Siren I Rettedal, PhD
• Phone: +47 45235742
• Email: siren.irene.rettedal[@]sus.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 60 Minutes

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Congenital malformations that interfere with the intervention, Non-consent

Related Conditions & MeSH terms

• Heart Rate Monitoring
• Newborn Resuscitation

Intervention

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.

Locations

Country	Name	City	State
Norway	Stavanger University Hospital	Stavanger	Rogaland

Sponsors (3)

Lead Sponsor	Collaborator
Helse Stavanger HF	Laerdal Medical, Sykehuset Østfold

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in time from birth to initiation of PPV	defined as seconds between birth and initiation of PPV	first 15 minutes of life
Secondary	Change in total duration of PPV	defined as seconds of PPV in total	first hour of life
Secondary	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
Secondary	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
Secondary	Adequate Vt delivered during PPV	defined as proportion of time of PPV with Vt = 6 ml/kg	first hour of life
Secondary	Change in ventilation fraction	defined as cumulative number of seconds with PPV efforts excluding pauses	first hour of life
Secondary	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
Secondary	Change in NICU admission rate after resuscitation	defined as percentage of newborns needing admission to the NICU after resuscitation	first hour of life