Heart Rate Monitoring, Newborn Resuscitation
Conditions
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.
Interventions
DEVICENeoBeat 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.
Sponsors
Sykehuset Østfold
Laerdal Medical
Helse Stavanger HF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 60 Minutes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in total duration of PPV | first hour of life | defined as seconds of PPV in total |
| 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 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 |
| 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 ventilation fraction | first hour of life | defined as cumulative number of seconds with PPV efforts excluding pauses |
| 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 |
| Adequate Vt delivered during PPV | first hour of life | defined as proportion of time of PPV with Vt ≥ 6 ml/kg |
Countries
Norway
Contacts
Primary ContactSiren I Rettedal, PhD
Backup ContactHege Ersdal, PhD
Outcome results
None listed