Newborn brain activity and oxygen monitoring immediately after birth
Evaluation of Cerebral, Hemodynamic and Neuronal Activities in Neonates in the Immediate Postpartum
NA · Centre Hospitalier Universitaire, Amiens · NCT04225975
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.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 1 Minute to 15 Minutes |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens (other) |
| Locations | 1 site (Amiens) |
| Trial ID | NCT04225975 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Amiens
- CHU Amiens — Amiens, France (RECRUITING)
Study contacts
- Study coordinator: Fabrice Wallois, Pr
- Email: fabrice.wallois@u-picardie.fr
- Phone: (33)322087775
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anoxia-Ischemia, Brain, Neonatal Encephalopathy, postpartum, Electroencephalography, Cerebral oxymetry, Near Infrared spectroscopy, EEG, NIRS