The NeoBeat Efficacy Study for Newborns

Not Applicable

• Conditions: Newborn Resuscitation; Heart Rate Monitoring
• Interventions: Device: NeoBeat with a visible display

• Registration Number: NCT03849781
• Lead Sponsor: Helse Stavanger HF

Brief 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.

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-21
• Study Start: 2019-03-08
• Last Update Submitted: 2019-05-13
• Last Update Posted: 2019-05-15
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

Congenital malformations that interfere with the intervention, Non-consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	NeoBeat with a visible display	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.

Primary Outcome Measures

Name	Time	Method
Proportion of cases with adherence to resuscitation guidelines in non-breathing newborns	First minute after birth	Defined as initiation of PPV within on minute

Secondary Outcome Measures

Name	Time	Method
Change in time for pulse oximeter saturation to reach stable values of ≥ 95% without oxygen supplementation	first hour of life	defined as seconds between birth to reach saturation values ≥ 95% without oxygen supplementation
Adequate Vt delivered during PPV	first hour of life	defined as proportion of time of PPV with Vt ≥ 6 ml/kg
Change in ventilation fraction	first hour of life	defined as cumulative number of seconds with PPV efforts excluding pauses
Change in time from birth to a stable HR ≥100 and 120 bpm	first hour of life	defined as HR ≥100 and 120 bpm for ≥ 60 seconds after discontinuing PPV
Change in total duration of PPV	first hour of life	defined as seconds of PPV in total
Change in time from birth to initiation of PPV	first 15 minutes of life	defined as seconds between birth and initiation of PPV
Change in number of infants with Apgar score <7 at 5 and 10 minutes	first 10 minutes of life	Apgar score at 5 and 10 minutes
Change in NICU admission rate after resuscitation	first hour of life	defined as percentage of newborns needing admission to the NICU after resuscitation

Trial Locations

Locations (1)

Stavanger University Hospital; 🇳🇴 Stavanger, Rogaland, Norway