Clinical trial NCT03849781: The NeoBeat Efficacy Study for Newborns
Official title: Enhanced Heart Rate Monitoring of Newborns After Birth and During Resuscitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Newborn Resuscitation
Heart Rate Monitoring
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: Sykehuset Østfold
name: Laerdal Medical
First posted: 2019-02-21
Enrollment: 500
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Congenital malformations that interfere with the intervention, Non-consent

Primary outcomes:
measure: Proportion of cases with adherence to resuscitation guidelines in non-breathing newborns
timeFrame: First minute after birth
Secondary outcomes:
measure: Change in time from birth to initiation of PPV
timeFrame: first 15 minutes of life
measure: Change in total duration of PPV
timeFrame: first hour of life
measure: Change in time from birth to a stable HR ≥100 and 120 bpm
timeFrame: first hour of life
measure: Change in time for pulse oximeter saturation to reach stable values of ≥ 95% without oxygen supplementation
timeFrame: first hour of life
measure: Adequate Vt delivered during PPV
timeFrame: first hour of life
measure: Change in ventilation fraction
timeFrame: first hour of life
measure: Change in number of infants with Apgar score <7 at 5 and 10 minutes
timeFrame: first 10 minutes of life
measure: Change in NICU admission rate after resuscitation
timeFrame: first hour of life
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
state: Rogaland
Study officials:
affiliation: Stavanger University Hosptial
name: Svein Skeie, MD PhD
role: STUDY_DIRECTOR
References: