Clinical trial Recruiting at 1 site Interventional Ages 1 Minute to 15 Minutes

Newborn brain activity and oxygen monitoring immediately after birth

Official title: Evaluation of Cerebral, Hemodynamic and Neuronal Activities in Neonates in the Immediate Postpartum

Run by Centre Hospitalier Universitaire, Amiens · NCT04225975 · Data updated 2026-11-12

This trial will test whether a single scalp sensor that records EEG and near-infrared oxymetry can track full-term newborns' brain electrical activity and oxygen levels during the first 15 minutes after birth.

More Neonatal Encephalopathy trials

Quick facts

Study typeInterventional
Ages1 Minute to 15 Minutes
SexAll
Enrollment60 (estimated)
SponsorCentre Hospitalier Universitaire, Amiens
Academic / other
Locations1 site (Amiens)
StatusRecruiting
StartedMarch 3, 2021
Main results expectedJanuary 2027
Study endsJanuary 2027
Registry record updatedMay 13, 2026
Trial IDNCT04225975 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Full-term newborns (36–41 weeks gestation), singletons without suspected congenital malformations, not requiring neonatal intensive care at birth, and born to mothers without chronic viral infections or multidrug-resistant bacteria.

Probably not a fit

Preterm infants, twins, newborns with antenatal-suspected congenital malformations, those needing immediate pediatric or intensive care at birth, or whose mothers have chronic viral infection or multidrug-resistant bacteria are not expected to benefit or be eligible.

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

What this trial studies

This interventional study records simultaneous electroencephalography (EEG) and near-infrared cerebral oxymetry with a single scalp sensor during the first 15 minutes after delivery to study neurovascular interactions in the immediate postpartum period. The investigators aim to characterize how neuronal and vascular systems adapt after birth and to detect early dysfunction related to anoxia-ischemia. Eligible participants are full-term singletons (36–41 weeks gestation) without major congenital anomalies or neonatal conditions requiring immediate pediatric care, and whose mothers do not have chronic viral infections or multidrug-resistant bacteria. All recordings and participation take place at the university hospital site in Amiens, France.

Why it matters

Potential benefit: If successful, this approach could provide an objective, immediate measure of cerebral oxygenation and electrical activity to help identify newborns at risk of brain injury and guide early care.

How similar studies have gone: Previous research has used EEG and near-infrared spectroscopy separately and in combination to study neonatal brain injury, but simultaneous single-sensor multimodal recording immediately in the first minutes after birth is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Full term neonates between 36 and 41 weeks Gestational Age

Exclusion Criteria:

* Premature neonates
* Neonates of twin pregnancy
* Suspicion of congenital malformation seen in antenatal ultrasound
* Any pathology requiring pediatric care from birth
* Newborns whose mothers had a chronic viral infection such as AIDS, hepatitis B or C, or who had a multidrug-resistant bacteria

Where it's running

  • CHU Amiens
    Amiens, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.