Enhanced Heart Rate Monitoring of Newborns After Birth and During Resuscitation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Newborn Resuscitation
- Sponsor
- Helse Stavanger HF
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Proportion of cases with adherence to resuscitation guidelines in non-breathing newborns
- Last Updated
- 6 years ago
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.
Investigators
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
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)