Actively Recruiting

Age: 0Minutes - 15Minutes
All Genders
ID05896306

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

Led by Medical University of Graz · Updated on 2025-11-19

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

The transition from fetus to newborn is a complex process that requires careful monitoring to detect any problems early. This trial focuses on neonatal disease by evaluating cerebral monitoring using a new pulsatile near-infrared spectroscopy (NIRS) method immediately after birth. Traditional methods like the Apgar score and standard monitoring of oxygen saturation and heart rate have limitations, especially in assessing brain oxygenation and blood flow during this critical time. The study is observational and aims to explore this innovative approach in newborns, including both term and preterm infants. The new pulsatile NIRS technique, used with the NIRO 200 NX device, measures cerebral pulse rate and arterial oxygen saturation in small brain vessels continuously and non-invasively. Unlike conventional NIRS, it captures data at a higher rate to provide better insight into brain oxygenation and blood flow. The study involves no intervention and observes neonates routinely at the resuscitation desk, with groups including term and preterm babies. This method could help identify brain oxygen supply issues early and guide potential interventions in the future. Participants, both term and preterm neonates, will be monitored right after birth during routine care at the resuscitation station. Researchers will measure the percentage of cerebral oxygenation in pulsatile cerebral vessels over 15 minutes. No active treatments are given as part of the study. The goal is to collect data that may improve understanding of brain oxygen delivery during the vulnerable newborn transition. The study requires parental consent and includes follow-up to ensure safety and accurate data collection during this early period of life.

CONDITIONS

Brief Title

Cerebral Monitoring Using Pulsatile Near Infrared Spectroscopy in Neonates

Who Can Participate

Age: 0Minutes - 15Minutes
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Term and preterm neonates observed routinely at the resuscitation desk
  • Decision to conduct full life support
  • Written parental informed consent
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Approximately 15 minutes

Participants undergo cerebral monitoring using pulsatile near infrared spectroscopy immediately after birth.

1 assessment immediately after birth

Long-term Monitoring

Duration - Up to hospital discharge

Participants are observed routinely after the initial cerebral monitoring without any intervention.

Observation during routine care

Trial Site Locations

Total: 1 location

1

Division Neonatology, Dep. Pediatrics

Graz, Styria, Austria, 8036

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Research Team

N

Nariae Baik-Schneditz, MD. PhD

B

Bernhard Schwaberger, MD.PhD.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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