Enhanced Heart Rate Monitoring of Newborns After Birth and During Resuscitation
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Helse Stavanger HF
- Enrollment
- 500
- Locations
- 2
- Primary Endpoint
- Proportion of cases with adherence to resuscitation guidelines in non-breathing newborns
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- — to 60 Minutes (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Inborn, Gestational age ≥ 28 weeks, Multiples according to availability of equipment
Exclusion Criteria
- •Congenital malformations that interfere with the intervention, Non-consent
Arms & Interventions
Intervention
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.
Intervention: NeoBeat with a visible display (Device)
Standard Care
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.
Outcomes
Primary Outcomes
Proportion of cases with adherence to resuscitation guidelines in non-breathing newborns
Time Frame: First minute after birth
Defined as initiation of PPV within on minute
Secondary Outcomes
- Change in time for pulse oximeter saturation to reach stable values of ≥ 95% without oxygen supplementation(first hour of life)
- Adequate Vt delivered during PPV(first hour of life)
- Change in ventilation fraction(first hour of life)
- Change in time from birth to a stable HR ≥100 and 120 bpm(first hour of life)
- Change in total duration of PPV(first hour of life)
- Change in time from birth to initiation of PPV(first 15 minutes of life)
- Change in number of infants with Apgar score <7 at 5 and 10 minutes(first 10 minutes of life)
- Change in NICU admission rate after resuscitation(first hour of life)