Assessment of Cerebral Monitoring Using the Pulsatile Near Infrared Spectroscopy in Neonates Immediately After Birth - a Prospective Observational Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: Newborn
Healthy Volunteers: f
View:

• Term and preterm neonates observed routinely at the resuscitation desk

• Decision to conduct full life support

• Written parental informed consent

Locations
Other Locations
Austria
Division Neonatology, Dep. Pediatrics
RECRUITING
Graz
Contact Information
Primary
Nariae Baik-Schneditz, MD. PhD
nariae.baik@medunigraz.at
+4331638582677
Backup
Bernhard Schwaberger, MD.PhD.
bernhard.schwaberger@medunigraz.at
+4331638530018
Time Frame
Start Date: 2023-05-30
Estimated Completion Date: 2025-05-31
Participants
Target number of participants: 40
Treatments
Term neonates
Preterm neonates
Related Therapeutic Areas
Sponsors
Leads: Medical University of Graz

This content was sourced from clinicaltrials.gov