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RecruitingNCT05896306pNIRSUpdated Nov 19, 2025

Cerebral Monitoring Using Pulsatile Near Infrared Spectroscopy in Neonates

An observational study in Neonatal Disease, sponsored by Medical University of Graz. Recruiting at 1 site in Austria. Open to participants aged 0 Minutes to 15 Minutes. Per ClinicalTrials.gov, last updated 2025-11-19.

Sponsored by Medical University of Graz · Observational

From the registry’s dates

  • Started May 2023; still recruiting 3 years 4 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
40
Ages
0 Minutes to 15 Minutes
Sex
All
01

Study 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.

02

Conditions studied

  • Neonatal Disease

Keywords

  • pNIRS
  • Neonates
  • Postnatal transition
03

In context

Infant, Newborn, Diseases

134 studies on the registry are indexed under Infant, Newborn, Diseases; 30 are open to participants now.

This study's planned enrollment of 40 is below the median of 114 across 50 observational studies indexed under Infant, Newborn, Diseases.

Browse Infant, Newborn, Diseases studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Minutes to 15 Minutes
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Term and preterm neonates after birth.

Inclusion criteria

  • Term and preterm neonates observed routinely at the resuscitation desk
  • Decision to conduct full life support
  • Written parental informed consent

Exclusion criteria

Exclusion Criteria:

  • No decision to conduct full life support
  • No written parental informed consent
  • Congenital malformation
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • Term neonates

    Other: No intervention

  • Preterm neonates

    Other: No intervention

Interventions

  • OtherNo intervention

    No intervention

06

What researchers measure

Primary outcomes

  1. Percentage of cerebral oxygenation in cerebral pusatile vessels

    cerebral oxygenation in pusatile vessels (SnO2)

    Time frame: 15 minutes

07

Study locations

1 of 1 sites recruiting
  • Division Neonatology, Dep. Pediatrics
    Graz, Styria 8036, Austria
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05896306
Lead sponsor
Medical University of Graz
Responsible party
Sponsor
First posted
Jun 9, 2023
Start date
May 30, 2023
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Nov 19, 2025

Study contacts

Nariae Baik-Schneditz, MD. PhD
Contact
nariae.baik@medunigraz.at
+4331638582677
Bernhard Schwaberger, MD.PhD.
Contact
bernhard.schwaberger@medunigraz.at
+4331638530018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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