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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
500
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.
Stavanger University Hospital
Stavanger, Rogaland, Norway
RECRUITINGProportion of cases with adherence to resuscitation guidelines in non-breathing newborns
Defined as initiation of PPV within on minute
Time frame: First minute after birth
Change in time from birth to initiation of PPV
defined as seconds between birth and initiation of PPV
Time frame: first 15 minutes of life
Change in total duration of PPV
defined as seconds of PPV in total
Time frame: first hour of life
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
Time frame: first hour of life
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
Time frame: first hour of life
Adequate Vt delivered during PPV
defined as proportion of time of PPV with Vt ≥ 6 ml/kg
Time frame: first hour of life
Change in ventilation fraction
defined as cumulative number of seconds with PPV efforts excluding pauses
Time frame: first hour of life
Change in number of infants with Apgar score <7 at 5 and 10 minutes
Apgar score at 5 and 10 minutes
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Time frame: first 10 minutes of life
Change in NICU admission rate after resuscitation
defined as percentage of newborns needing admission to the NICU after resuscitation
Time frame: first hour of life