Clinical trial Recruiting at 1 site Observational Ages 0 Minutes to 15 Minutes

Monitoring brain activity in newborns using near-infrared technology

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

Run by Medical University of Graz · NCT05896306 · Data updated 2026-11-12

This study is testing a new way to monitor brain activity in newborns using special light technology to see how they are doing during their important transition from fetus to baby.

Quick facts

Study typeObservational
Ages0 Minutes to 15 Minutes
SexAll
Enrollment40 (estimated)
SponsorMedical University of Graz
Academic / other
Locations1 site (Graz, Styria)
StatusRecruiting
StartedMay 30, 2023
Main results expectedMay 31, 2027
Study endsMay 31, 2027
Registry record updatedOctober 20, 2026
Trial IDNCT05896306 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are term and preterm neonates who are being observed at the resuscitation desk and for whom full life support is being considered.

Probably not a fit

Patients who may not benefit from this study include those with congenital malformations or those for whom a decision has been made not to conduct full life support.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to monitor the physiological transition of neonates from fetus to newborn using pulsatile near-infrared spectroscopy (pNIRS). It focuses on assessing the condition of newborns during this critical period, where traditional methods like the Apgar score may have variability. The study will involve term and preterm neonates who are routinely observed at the resuscitation desk, with parental consent obtained for participation. The goal is to provide objective data on the newborn's condition without any invasive interventions.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate monitoring of newborns during their critical transition period, potentially improving outcomes.

How similar studies have gone: While the use of pNIRS in neonates is a relatively novel approach, other studies have shown promise in using advanced monitoring techniques for neonatal care.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

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

Where it's running

  • Division Neonatology, Dep. Pediatrics
    Graz, Styria, Austria
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.