Cerebral Monitoring Using Pulsatile Near Infrared Spectroscopy in Neonates - Trial NCT05896306

Timeline & Enrollment

Primary Outcome

Percentage of cerebral oxygenation in cerebral pusatile vessels

Summary

The transition from fetus to newborn is a complex physiological process. Monitoring this
 process to detect potential disruptions is critical but remains a challenge. Initial
 evaluation of neonates is usually based on visual inspection, palpation and/or auscultation,
 and response to stimuli. To objectify the condition of the newborn during this vulnerable
 transitional period, Virginia Apgar developed a clinical assessment-based scoring system
 called the Apgar Score, which is widely used around the world. However, there is significant
 inter-observer and intra-observer variability in clinical assessments using the Apgar score.
 To objectively assess the condition of the newborn, the latest guidelines for postnatal
 adaptation and resuscitation recommend the use of electrocardiography (ECG) and pulse
 oximetry in the delivery room in addition to clinical evaluation. These monitoring methods
 allow non-invasive continuous monitoring of SpO2 (Oxygen saturation) as well as heart rate
 (HR), but do not provide information about potentially compromised cardiovascular status,
 resulting in severely restricted oxygen transport to tissues.
 
 Cerebral Oxygenation:
 
 The brain is one of the most vulnerable organs to hypoxia during the postnatal adaptation
 period. The recommended routine monitoring during the neonatal transition is SpO2 and heart
 rate. Unfortunately, these parameters do not provide any information about cerebral blood
 flow or oxygen supply or brain activity. About 30% of premature babies develop cerebral
 hemorrhage in the first 3 days after birth. This can lead to the development of
 hydrocephalus, poor neurological outcome and even death. For the above reasons, there is
 increasing interest in additional brain monitoring. Our research group has already shown in
 various studies that additional cerebral monitoring using near-infrared spectroscopy (NIRS)
 is possible in newborns immediately after birth and may be beneficial during this vulnerable
 phase of life. Furthermore, this add-on monitoring could inform interventions to optimize
 brain oxygenation, potentially affecting survival with improved short- and long-term
 neurological outcomes.
 
 Background:
 
 The transition from fetus to newborn is a complex physiological process. Monitoring this
 process to detect potential disruptions is critical but remains a challenge. Initial
 evaluation of neonates is usually based on visual inspection, palpation and/or auscultation,
 and response to stimuli. To objectify the condition of the newborn during this vulnerable
 transitional period, Virginia Apgar developed a clinical assessment-based scoring system
 called the Apgar Score, which is widely used around the world. However, there is significant
 inter-observer and intra-observer variability in clinical assessments using the Apgar score.
 To objectively assess the condition of the newborn, the latest guidelines for postnatal
 adaptation and resuscitation recommend the use of electrocardiography (ECG) and pulse
 oximetry in the delivery room in addition to clinical evaluation. These monitoring methods
 allow non-invasive continuous monitoring of SpO2 as well as HR, but do not provide
 information about potentially compromised cardiovascular status, resulting in severely
 restricted oxygen transport to tissues.
 
 Pulsatile mode of NIRS Recently, Hamamatsu developed new software and implemented it as a
 pulsatile mode in one of their near-infrared spectroscopy (NIRS) instruments, the NIRO 200
 NX. In contrast to the conventional NIRS technique, which measures tissue saturation closer
 to venous oxygen saturation than arterial oxygen saturation, the pulsatile NIRS technique
 uses a higher measurement rate of 20 Hertz and can therefore measure cerebral pulse rate
 (cPR) and cerebral arterial oxygen saturation (SnO2) in small vessels.
 
 Using the non-invasive pulsatile NIRS technique could be a viable new method to continuously
 monitor blood flow to the brain during resuscitation. This can be particularly beneficial for
 critically ill newborns and premature babies.
 
 To date, no data have been published in neonates using the pulsatile NIRS technique.

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