Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sykehuset Østfold | UNKNOWN |
| Laerdal Medical | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | 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. |
|
| Standard Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeoBeat with a visible display | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of cases with adherence to resuscitation guidelines in non-breathing newborns | Defined as initiation of PPV within on minute | First minute after birth |
| Measure | Description | Time Frame |
|---|---|---|
| Change in time from birth to initiation of PPV | defined as seconds between birth and initiation of PPV | first 15 minutes of life |
| Change in total duration of PPV | defined as seconds of PPV in total |
Not provided
Inclusion Criteria:
Inborn, Gestational age ≥ 28 weeks, Multiples according to availability of equipment
Exclusion Criteria:
Congenital malformations that interfere with the intervention, Non-consent
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Siren I Rettedal, PhD | Contact | +47 45235742 | siren.irene.rettedal@sus.no | |
| Hege Ersdal, PhD | Contact | 05151 | hege.ersdal@safer.net |
| Name | Affiliation | Role |
|---|---|---|
| Svein Skeie, MD PhD | Stavanger University Hosptial | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stavanger University Hospital | Recruiting | Stavanger | Rogaland | 4068 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37940377 | Derived | Rettedal S, Kibsgaard A, Kvaloy JT, Eilevstjonn J, Ersdal HL. Prevalence of bradycardia in 4876 newborns in the first minute after birth and association with positive pressure ventilation: a population-based cross-sectional study. Arch Dis Child Fetal Neonatal Ed. 2024 Jun 19;109(4):371-377. doi: 10.1136/archdischild-2023-325878. | |
| 36691167 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 | 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 | first hour of life |
| Adequate Vt delivered during PPV | defined as proportion of time of PPV with Vt ≥ 6 ml/kg | first hour of life |
| Change in ventilation fraction | defined as cumulative number of seconds with PPV efforts excluding pauses | 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 | first 10 minutes of life |
| Change in NICU admission rate after resuscitation | defined as percentage of newborns needing admission to the NICU after resuscitation | first hour of life |
| Rettedal S, Kibsgaard A, Eilevstjonn J, Kvaloy JT, Bjorland PA, Markhus Pike H, Haynes J, Tysland TB, Stordal K, Holte K, Davis PG, Ersdal HL. Impact of immediate and continuous heart rate feedback by dry electrode ECG on time to initiation of ventilation after birth: protocol for a randomised controlled trial. BMJ Open. 2022 Sep 7;12(9):e061839. doi: 10.1136/bmjopen-2022-061839. |