Primary Objective: To assess the agreement between the heart rate assessed with a dedicated cap with integrated PPG-leads and standard ECG monitoring using regular neonatal thoracic electrodes as reference technique.Secondary objectives:Does…
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the heart rate. The primary endpoint is the
agreement of heart rate monitoring between innovative PPG technology integrated
in a cap and standard heart rate monitoring using regular thoracic ECG
electrodes.
Secondary outcome
• Time interval between birth and the first adequate registration of the heart
rate
• Time interval between application of monitoring device and adequate
registration of the heart rate
• Feasibility, accuracy and precision when the innovative cap is used in an
infant who is supported by invasive or non-invasive respiratory support (e.g.
nCPAP, NiPPV, HFO-V).
Background summary
About 10% of newborns require some assistance during transition after birth;
about 1% are in need of more extensive resuscitation (1). The initial postnatal
evaluation includes the assessment of the heart rate.
Studies have shown that clinicians have trouble measuring the heart rate with a
stethoscope (1,2) and that pulse oximetry underestimate the HR compared with
ECG-electrodes during the first 7 minutes of life (3). The gold standard
reference technology for HR-monitoring is ECG. But some studies have shown that
even ECG may take up to 82 seconds before the heart rate can be accurately
assessed (4).
Moreover, almost all infants admitted to the neonatal ward require monitoring
of their vital signs. The heart rate of those infants who are especially
vulnerable, the extremely preterm infants (gestational age < 26 weeks), cannot
be monitored via conventional ECG-electrodes due to the sensitivity of their
skin. They are however most at risk for bradycardia secondary to apneas,
related to their immaturity. Currently only pulse oximetry is used for heart
rate monitoring in these extreme preterm infants, unless an (umbilical)
arterial catheter is in place. Which can measure the HR and blood pressure For
neonates born at a gestational age of 26 weeks or higher, ECG-monitoring using
regular thoracic neonatal electrodes is standard practise.
Use of a cap with integrated PPG leads could help clinicians assess the heart
frequency to determine when resuscitation should be initiated or ceased without
damaging the skin. It could also help monitor extremely preterm infants more
closely in the NICU.
Since the cap has wireless leads, it will not interfere with Kangaroo care.
Study objective
Primary Objective:
To assess the agreement between the heart rate assessed with a dedicated cap
with integrated PPG-leads and standard ECG monitoring using regular neonatal
thoracic electrodes as reference technique.
Secondary objectives:
Does simultaneous use of nCPAP or HFO-V influence the accuracy of heart rate
monitoring using the dedicated cap?
How quickly can a reliable heart rate be obtained in the delivery room?
Study design
Single center, prospective comparative study in the neonatal ward of the
Radboudumc Amalia children*s hospital.
Study burden and risks
All neonates will receive treatment according to our current protocol of
measuring heart rate.
The burden of participation will be low because it is already standard practice
to put on a cap after birth.
The burden for our study population will consist of removing the PPG-sensor
immediately after data acquisition, the cap itself can remain on the neonate's
head.
The cap is CE certified for all newborn babies including extremely premature
neonates.
No adverse effects have been described in earlier studies. Studies which have
also included premature babies.
Geert groteplein zuid 10
Nijmegen 6525 GA
NL
Geert groteplein zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• Gestational age
a. group 1: neonates born at a gestational age of >=32 weeks with standard
cardiorespiratory monitoring.
b. group 2: neonates born at a gestational age of >=26 weeks with or without
nCPAP (Nasal continuous positive airway pressure).
c. Phase 2/ group 3: Extreme preterm infants born at a gestational age between
24 and 26 weeks.
d. Group 4: Term and preterm newborn infants at birth
• Informed consent from parents or caregivers
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• nCPAP (group 1)
• Cerebral Function Monitoring (group 1, 2 and 3)
• Peripheral intravenous catheter located on the skull (group 1, 2 and 3)
• Skin lesions on the skull
• Life-threatening congenital defects
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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In other registers
| Register | ID |
|---|---|
| CCMO | NL72793.091.20 |